The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Disposable Bipolar Card.
| Device ID | K851487 |
| 510k Number | K851487 |
| Device Name: | CODMAN DISPOSABLE BIPOLAR CARD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Donald A Lincoln |
| Correspondent | Donald A Lincoln Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886704004360 | K851487 | 000 |
| 00381780513561 | K851487 | 000 |
| 30381780514774 | K851487 | 000 |
| 30381780513920 | K851487 | 000 |
| 20886704036019 | K851487 | 000 |
| 20886704006111 | K851487 | 000 |