The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Cryo 5.
| Device ID | K040727 |
| 510k Number | K040727 |
| Device Name: | CRYO 5 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH JUNKERSSTRASSE 9 Neu-ulm, DE D-89231 |
| Contact | Stefan Leinweber |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-03-22 |
| Decision Date | 2004-04-23 |
| Summary: | summary |