The following data is part of a premarket notification filed by Erbe Elektromedizin Gmbh with the FDA for Erbokryo Ca Cryosurgical System.
| Device ID | K934261 |
| 510k Number | K934261 |
| Device Name: | ERBOKRYO CA CRYOSURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ERBE ELEKTROMEDIZIN GMBH 728 LAURINDA LN. Orange, CA 92669 |
| Contact | Oralie Enos |
| Correspondent | Oralie Enos ORALIE ENOS 728 LAURINDA LN. Orange, CA 92669 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1994-04-26 |