The following data is part of a premarket notification filed by Protech, Inc. with the FDA for Protech Plus.
Device ID | K983547 |
510k Number | K983547 |
Device Name: | PROTECH PLUS |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | PROTECH, INC. 6421 CONGRESS AVENUE, #102 Boca Raton, FL 33487 |
Contact | Barry Bloch |
Correspondent | Barry Bloch PROTECH, INC. 6421 CONGRESS AVENUE, #102 Boca Raton, FL 33487 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-09 |
Decision Date | 1999-01-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PROTECH PLUS 85927349 4454716 Live/Registered |
Unifirst Corporation 2013-05-09 |