The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Quick Release Limb Holder.
| Device ID | K801272 |
| 510k Number | K801272 |
| Device Name: | TECNOL QUICK RELEASE LIMB HOLDER |
| Classification | Restraint, Protective |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-06-17 |