The following data is part of a premarket notification filed by Dermacare with the FDA for Disposable Bipolar Cord And Bipolar Forcep.
| Device ID | K884656 |
| 510k Number | K884656 |
| Device Name: | DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DERMACARE 7651 NATIONAL TURNPIKE Louisville, KY 40214 |
| Contact | Ryan M Sell |
| Correspondent | Ryan M Sell DERMACARE 7651 NATIONAL TURNPIKE Louisville, KY 40214 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1988-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942352012 | K884656 | 000 |