The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Surgitek Disposable Bipolar Cord.
| Device ID | K871910 |
| 510k Number | K871910 |
| Device Name: | SURGITEK DISPOSABLE BIPOLAR CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
| Contact | Ken Potts |
| Correspondent | Ken Potts DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-18 |
| Decision Date | 1987-06-01 |