The following data is part of a premarket notification filed by Aquatemp Service Co., Inc. with the FDA for Relax-o-guard.
| Device ID | K925064 |
| 510k Number | K925064 |
| Device Name: | RELAX-O-GUARD |
| Classification | Positioner, Tooth, Preformed |
| Applicant | AQUATEMP SERVICE CO., INC. 58-C SOUTH ST. Morristown, NJ 07960 |
| Contact | Paul J Dudeck |
| Correspondent | Paul J Dudeck AQUATEMP SERVICE CO., INC. 58-C SOUTH ST. Morristown, NJ 07960 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-06 |
| Decision Date | 1993-09-13 |