The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Rf-12 Disposable Scalp Clip Applier.
| Device ID | K894778 |
| 510k Number | K894778 |
| Device Name: | CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER |
| Classification | Clip, Scalp |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | G Cloutier |
| Correspondent | G 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 | 1989-07-27 |
| Decision Date | 1989-12-06 |