The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Micro Electrodes.
| Device ID | K971838 |
| 510k Number | K971838 |
| Device Name: | MICRO ELECTRODES |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Contact | Debra A Pekar |
| Correspondent | Debra A Pekar COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-11-05 |
| Summary: | summary |