The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Erbokryo Ca Cryosurgical Unit & Accessories.
| Device ID | K051509 |
| 510k Number | K051509 |
| Device Name: | ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ERBE USA, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens ERBE USA, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2005-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147019737 | K051509 | 000 |
| 04050147019515 | K051509 | 000 |
| 04050147008687 | K051509 | 000 |
| 04050147008038 | K051509 | 000 |
| 04050147007994 | K051509 | 000 |