The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbecryo 2 Cryosurgical Unit With Accessories.
| Device ID | K151041 |
| 510k Number | K151041 |
| Device Name: | ERBECRYO 2 Cryosurgical Unit With Accessories |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-05-04 |
| Summary: | summary |