The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Disposable Abdominal Binder.
| Device ID | K760772 |
| 510k Number | K760772 |
| Device Name: | DISPOSABLE ABDOMINAL BINDER |
| Classification | Binder, Abdominal |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
| Product Code | FSD |
| CFR Regulation Number | 880.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-04 |
| Decision Date | 1976-11-03 |