The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Kwikap.
Device ID | K772315 |
510k Number | K772315 |
Device Name: | KWIKAP |
Classification | Zinc Oxide Eugenol |
Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EMB |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-19 |
Decision Date | 1978-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KWIKAP 73044406 1023102 Dead/Expired |
C. R. CANFIELD & COMPANY, INC. 1975-02-18 |