The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Suture Wound Tray Milford Whittinsville.
| Device ID | K802386 |
| 510k Number | K802386 |
| Device Name: | SUTURE WOUND TRAY MILFORD WHITTINSVILLE |
| Classification | Patient Examination Glove |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-02 |
| Decision Date | 1980-11-12 |