Pollogen Ltd · 89-08 · ISRAEL
For Pollogen Ltd · 89-08 · ISRAEL, 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 ISRAEL; product is Pollogen Apollo; product code is 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat; date published is 09/16/2009; address is 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL, verified against its source on 2026-09-16.
- Firm
- Pollogen 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
- ISRAEL verified
- Address
- 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL verified
- Date published
- 09/16/2009 verified
- Product code
- 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat each item verified
- Product
- Pollogen Apollo verified
- FDA notes
- Class III; 5/12/2009 | Pollogen Regan; 5/12/2009; Class III each item verified
What the source says
Pollogen Ltd Date Published : 09/16/2009 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 06/29/2018 Desc: Pollogen Apollo Notes: Class III; 5/12/2009 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 09/16/2009 Notes: Pollogen Regan; 5/12/2009; Class III
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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