The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries, Inc. Electrosurgical Cautery Pencil.
| Device ID | K961647 |
| 510k Number | K961647 |
| Device Name: | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Camille Matlock |
| Correspondent | Camille Matlock DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-10-08 |
| Summary: | summary |