The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Tuxedo Vest Restraint.
| Device ID | K963474 |
| 510k Number | K963474 |
| Device Name: | TUXEDO VEST RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Camille Matlock |
| Correspondent | Camille Matlock DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1997-01-22 |
| Summary: | summary |