ORBISAN LTD · 89-08 · MALTA
For ORBISAN LTD · 89-08 · MALTA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is MALTA; product is Penis Extender | Penis Extender | Penis Extender | Penis Extender; product code is 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) | 89 I - - SA Massager, Therapeutic, Electric; date published is 05/23/2012; address is Ub3a Industrial Estate , San Gwann, San Gwann MALTA, verified against its source on 2026-09-16.
- Firm
- ORBISAN LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- MALTA verified
- Address
- Ub3a Industrial Estate , San Gwann, San Gwann MALTA verified
- Date published
- 05/23/2012 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Penis Extender | Penis Extender | Penis Extender | Penis Extender each item verified
- FDA notes
- Class II | class II | Class II | class II each item verified
What the source says
ORBISAN LTD Date Published : 05/23/2012 Ub3a Industrial Estate , San Gwann, San Gwann MALTA 78 L - - KY Device, External Penile Rigidity Date Published: 05/23/2012 Desc: Penis Extender Notes: Class II 78 N - - HU Extender, Penile, Mechanical Date Published: 05/23/2012 Desc: Penis Extender Notes: class II 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) Date Published: 05/23/2012 Desc: Penis Extender Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/23/2012 Desc: Penis Extender Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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