The following data is part of a premarket notification filed by Majestic Drug Co., Inc. with the FDA for Reline-it Model Reline-it.
| Device ID | K101771 |
| 510k Number | K101771 |
| Device Name: | RELINE-IT MODEL RELINE-IT |
| Classification | Reliner, Denture, Over The Counter |
| Applicant | MAJESTIC DRUG CO., INC. 848-1/2 DERBY AVENUE Orange, CT 06477 |
| Contact | Roger S Mastrony |
| Correspondent | Roger S Mastrony MAJESTIC DRUG CO., INC. 848-1/2 DERBY AVENUE Orange, CT 06477 |
| Product Code | EBP |
| CFR Regulation Number | 872.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-24 |
| Decision Date | 2010-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00010705400968 | K101771 | 000 |