The following data is part of a premarket notification filed by United States Medical Corp. with the FDA for Modified Articulating Endoscopic Clamp.
Device ID | K925150 |
510k Number | K925150 |
Device Name: | MODIFIED ARTICULATING ENDOSCOPIC CLAMP |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | UNITED STATES MEDICAL CORP. 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Curtis Raymond |
Correspondent | Curtis Raymond UNITED STATES MEDICAL CORP. 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-13 |
Decision Date | 1993-02-26 |