Storz Medical, AG · 89-08 · SWITZERLAND
For Storz Medical, AG, import alert is 89-08; country is SWITZERLAND; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
89 O - - OV Evopace system and accessories Date Published: 04/27/2010 Desc: D-Actor 50 Shockwave device Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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