The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Gardner Pins (adult & Child).
| Device ID | K911772 |
| 510k Number | K911772 |
| Device Name: | GARDNER PINS (ADULT & CHILD) |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Thomas J Courage |
| Correspondent | Thomas J Courage Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-19 |
| Decision Date | 1991-08-26 |