The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter.
| Device ID | K060183 |
| 510k Number | K060183 |
| Device Name: | ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30157 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30157 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-24 |
| Decision Date | 2006-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147020191 | K060183 | 000 |
| 04050147014824 | K060183 | 000 |
| 04050147014060 | K060183 | 000 |
| 04050147014039 | K060183 | 000 |
| 04050147014015 | K060183 | 000 |
| 04050147013988 | K060183 | 000 |
| 04050147013940 | K060183 | 000 |
| 04050147013919 | K060183 | 000 |
| 04050147013896 | K060183 | 000 |