The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Unimed Disposable Hand And Foot-switching Pencils With Holster And 1blade And Tip Cleaner, Unimed Disposable Hand And F.
| Device ID | K993647 |
| 510k Number | K993647 |
| Device Name: | UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 33777 |
| Contact | Lee Alexander |
| Correspondent | Lee Alexander UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 33777 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-29 |
| Decision Date | 1999-11-16 |
| Summary: | summary |