The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Nova Gauze.
Device ID | K830473 |
510k Number | K830473 |
Device Name: | NOVA GAUZE |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-15 |
Decision Date | 1983-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOVA GAUZE 73419421 1380995 Live/Registered |
AMERICAN THRESHOLD INDUSTRIES, INC. 1983-03-29 |