Storz Medical, AG · 89-08 · SWITZERLAND
For Storz Medical, AG · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is D-Actor 50 Shockwave device; product code is 89 O - - OV Evopace system and accessories; date published is 04/27/2010; address is Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND, verified against its source on 2026-09-16.
- Firm
- Storz Medical, AG 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
- SWITZERLAND verified
- Address
- Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND verified
- Date published
- 04/27/2010 verified
- Product code
- 89 O - - OV Evopace system and accessories verified
- Product
- D-Actor 50 Shockwave device verified
- FDA notes
- Class III verified
What the source says
Storz Medical, AG Date Published : 04/27/2010 Lohstampfestrasse 8 , Tagerwilen, Thurgau SWITZERLAND 89 O - - OV Evopace system and accessories Date Published: 04/27/2010 Desc: D-Actor 50 Shockwave device Notes: 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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