The following data is part of a premarket notification filed by Medical/surgical Specialties, Ltd. with the FDA for Disp. Electrosurgery Pencil, Hand Control.
| Device ID | K900633 |
| 510k Number | K900633 |
| Device Name: | DISP. ELECTROSURGERY PENCIL, HAND CONTROL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDICAL/SURGICAL SPECIALTIES, LTD. 1611 W. CENTRE ST. Kalamazoo, MI 49002 |
| Contact | James L Phillips |
| Correspondent | James L Phillips MEDICAL/SURGICAL SPECIALTIES, LTD. 1611 W. CENTRE ST. Kalamazoo, MI 49002 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-08 |
| Decision Date | 1990-05-07 |