The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for New Super Poli-grip Denture Adhesive Cream.
Device ID | K862876 |
510k Number | K862876 |
Device Name: | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM |
Classification | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
Applicant | BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
Contact | Howard Feinman |
Correspondent | Howard Feinman BLOCK DRUG COMPANY, INC. 257 CORNELISON AVE. Jersey City, NJ 07302 |
Product Code | KOO |
CFR Regulation Number | 872.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-30 |
Decision Date | 1986-08-29 |