The following data is part of a premarket notification filed by Teledyne Getz with the FDA for Super Strength Denture Adhesive Cream.
| Device ID | K901938 |
| 510k Number | K901938 |
| Device Name: | SUPER STRENGTH DENTURE ADHESIVE CREAM |
| Classification | Catheter, Suprapubic (and Accessories) |
| 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 | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-06-06 |