The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for Super Poli-grip Denture Adhesive Cream.
Device ID | K945462 |
510k Number | K945462 |
Device Name: | SUPER POLI-GRIP DENTURE ADHESIVE CREAM |
Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
Applicant | BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
Contact | Filomena King |
Correspondent | Filomena King BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
Product Code | KOT |
CFR Regulation Number | 872.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-07 |
Decision Date | 1994-12-20 |