The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Laser Neuroendoscope.
| Device ID | K924977 |
| 510k Number | K924977 |
| Device Name: | CODMAN LASER NEUROENDOSCOPE |
| Classification | Endoscope, Neurological |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Nancy Adelstein |
| Correspondent | Nancy Adelstein Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-01 |
| Decision Date | 1993-11-22 |