The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Biclamp Open And Laparoscopic Instruments.
| Device ID | K033421 |
| 510k Number | K033421 |
| Device Name: | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-27 |
| Decision Date | 2004-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147020450 | K033421 | 000 |
| 04050147006461 | K033421 | 000 |
| 04050147006478 | K033421 | 000 |
| 04050147006485 | K033421 | 000 |
| 04050147006492 | K033421 | 000 |
| 04050147006508 | K033421 | 000 |
| 04050147006515 | K033421 | 000 |
| 04050147006522 | K033421 | 000 |
| 04050147006539 | K033421 | 000 |
| 04050147006546 | K033421 | 000 |
| 04050147020436 | K033421 | 000 |
| 04050147020443 | K033421 | 000 |
| 04050147006454 | K033421 | 000 |