The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol O.r. Tourniquet Cover.
| Device ID | K802850 |
| 510k Number | K802850 |
| Device Name: | TECNOL O.R. TOURNIQUET COVER |
| Classification | Tourniquet, Gastro-urology |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
| Product Code | EYR |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-12 |
| Decision Date | 1981-01-13 |