The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Endoscope.
Device ID | K944555 |
510k Number | K944555 |
Device Name: | ENDOSCOPE |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Jonathan Gilbert |
Correspondent | Jonathan Gilbert UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-16 |
Decision Date | 1994-12-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENDOSCOPE 98127497 not registered Live/Pending |
CHEN, XIAOFENG 2023-08-10 |