The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Flexible Endoscope.
| Device ID | K871978 |
| 510k Number | K871978 |
| Device Name: | CODMAN FLEXIBLE ENDOSCOPE |
| Classification | Endoscope, Flexible |
| 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 | GCQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-22 |
| Decision Date | 1987-08-25 |