The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Surgical Retractor.
Device ID | K760422 |
510k Number | K760422 |
Device Name: | SURGICAL RETRACTOR |
Classification | Retractor |
Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-10 |
Decision Date | 1976-08-23 |