The following data is part of a premarket notification filed by Genicon with the FDA for Genicon Bipolar Forceps Model # 600-005-005.
| Device ID | K041968 |
| 510k Number | K041968 |
| Device Name: | GENICON BIPOLAR FORCEPS MODEL # 600-005-005 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GENICON 427 LAKE HOWELL Maitland, FL 32751 |
| Contact | Gary Haberland |
| Correspondent | Gary Haberland GENICON 427 LAKE HOWELL Maitland, FL 32751 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-21 |
| Decision Date | 2004-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972006336 | K041968 | 000 |
| 00877972006312 | K041968 | 000 |
| 00877972006299 | K041968 | 000 |
| 00877972006275 | K041968 | 000 |
| 00877972006619 | K041968 | 000 |