The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Cryo, Model V6.0.
| Device ID | K060395 |
| 510k Number | K060395 |
| Device Name: | CRYO, MODEL V6.0 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRASSE 9 Neu-ulm, DE 89231 |
| Contact | Armin Petraschka |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 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 | 2006-02-15 |
| Decision Date | 2006-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815044635 | K060395 | 000 |
| 04053815003618 | K060395 | 000 |
| 04053815079163 | K060395 | 000 |