The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Disposable Scalp Clip Applier.
| Device ID | K905433 |
| 510k Number | K905433 |
| Device Name: | CODMAN DISPOSABLE SCALP CLIP APPLIER |
| Classification | Clip, Scalp |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Jeanette Cloutier |
| Correspondent | Jeanette Cloutier Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | HBO |
| CFR Regulation Number | 882.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1991-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886704001161 | K905433 | 000 |
| 10381780511649 | K905433 | 000 |
| 00381780511635 | K905433 | 000 |
| 10886704001171 | K905433 | 000 |