The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Criss-cross Vest Restraint.
Device ID | K963470 |
510k Number | K963470 |
Device Name: | CRISS-CROSS 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 | 1996-11-14 |
Summary: | summary |