The following data is part of a premarket notification filed by Verg, Inc. with the FDA for Verge Videometer.
Device ID | K962148 |
510k Number | K962148 |
Device Name: | VERGE VIDEOMETER |
Classification | Tape, Camera, Surgical |
Applicant | VERG, INC. 633 WELLINGTON CRESCENT Winnipeg, Manitoba, CA R3m 0a8 |
Contact | Vernon C Taylor |
Correspondent | Vernon C Taylor VERG, INC. 633 WELLINGTON CRESCENT Winnipeg, Manitoba, CA R3m 0a8 |
Product Code | FXN |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-03 |
Decision Date | 1996-12-20 |