The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Apc 300 Argon Plasma Coagulator And Accessories - Argon Plasma Coagulator And Accessories.
| Device ID | K963189 |
| 510k Number | K963189 |
| Device Name: | ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk ERBE USA, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1996-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147005068 | K963189 | 000 |
| 04050147002678 | K963189 | 000 |
| 04050147002623 | K963189 | 000 |
| 04050147002562 | K963189 | 000 |
| 04050147020474 | K963189 | 000 |
| 04050147000629 | K963189 | 000 |