The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Isocool Bipolar Forceps.
| Device ID | K083895 |
| 510k Number | K083895 |
| Device Name: | CODMAN ISOCOOL BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Emily E Valerio |
| Correspondent | Emily E Valerio 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 | 2008-12-29 |
| Decision Date | 2009-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780519546 | K083895 | 000 |
| 10886704041719 | K083895 | 000 |
| 10886704040224 | K083895 | 000 |
| 10886704040217 | K083895 | 000 |
| 10886704040200 | K083895 | 000 |
| 10886704040194 | K083895 | 000 |
| 10886704040187 | K083895 | 000 |
| 10886704040170 | K083895 | 000 |
| 10886704040163 | K083895 | 000 |
| 10886704040156 | K083895 | 000 |
| 10886704040149 | K083895 | 000 |
| 10886704040132 | K083895 | 000 |
| 10886704040125 | K083895 | 000 |
| 10886704040118 | K083895 | 000 |
| 10886704073536 | K083895 | 000 |
| 10381780514565 | K083895 | 000 |
| 10381780517412 | K083895 | 000 |
| 10381780517405 | K083895 | 000 |
| 10381780517399 | K083895 | 000 |
| 10381780517382 | K083895 | 000 |
| 10381780517375 | K083895 | 000 |
| 10381780517368 | K083895 | 000 |
| 10381780517351 | K083895 | 000 |
| 10381780517344 | K083895 | 000 |
| 10381780517337 | K083895 | 000 |
| 10381780517320 | K083895 | 000 |
| 10381780517313 | K083895 | 000 |
| 10381780517306 | K083895 | 000 |
| 10381780514572 | K083895 | 000 |
| 10886704035756 | K083895 | 000 |