The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries, Inc. Pneumatic Tourniquet Cuff.
| Device ID | K953953 |
| 510k Number | K953953 |
| Device Name: | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF |
| Classification | Tourniquet, Pneumatic |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Mitzi Y Shearer |
| Correspondent | Mitzi Y Shearer DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-09-29 |