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 |