The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Steerable Endoscope (cat.# 83-1340).
| Device ID | K920979 |
| 510k Number | K920979 |
| Device Name: | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) |
| Classification | Endoscope, Flexible |
| Applicant | Codman & Shurtleff, Inc. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale Codman & Shurtleff, Inc. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | GCQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1993-03-23 |