The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Isocool Bipolar Forceps.
| Device ID | K023566 |
| 510k Number | K023566 |
| Device Name: | CODMAN ISOCOOL BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Elizabeth Dolan |
| Correspondent | Elizabeth Dolan Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2003-05-22 |
| Summary: | summary |