The following data is part of a premarket notification filed by Medcare Products with the FDA for Disposable Thumb Forceps.
| Device ID | K821143 |
| 510k Number | K821143 |
| Device Name: | DISPOSABLE THUMB FORCEPS |
| Classification | Forceps, General & Plastic Surgery |
| Applicant | MEDCARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEN |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-21 |
| Decision Date | 1982-05-21 |