The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Endoscope And Accessories.
Device ID | K790071 |
510k Number | K790071 |
Device Name: | ENDOSCOPE AND ACCESSORIES |
Classification | Endoscope, Ac-powered And Accessories |
Applicant | OLYMPUS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GCP |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-11 |
Decision Date | 1979-04-02 |