The following data is part of a premarket notification filed by Teledyne Getz with the FDA for Super Strength Denture Adhesive Cream.
Device ID | K903568 |
510k Number | K903568 |
Device Name: | SUPER STRENGTH DENTURE ADHESIVE CREAM |
Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
Applicant | TELEDYNE GETZ 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 -5525 |
Contact | Gabriel Lebovic |
Correspondent | Gabriel Lebovic TELEDYNE GETZ 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 -5525 |
Product Code | KOT |
CFR Regulation Number | 872.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-07 |
Decision Date | 1990-10-24 |