The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Cryomini.
| Device ID | K080735 |
| 510k Number | K080735 |
| Device Name: | CRYOMINI |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRASSE 9 Neu-ulm, DE 89231 |
| Contact | Armin Petraschka |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815003090 | K080735 | 000 |
| 04053815003083 | K080735 | 000 |