The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Electrosurgical Pencil, Rocker Style Without Holster, Deroyal Electrosurgical Pencil, Button Style Without Holst.
| Device ID | K132199 |
| 510k Number | K132199 |
| Device Name: | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Courtney Rinehart |
| Correspondent | Courtney Rinehart 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 | 2013-07-16 |
| Decision Date | 2013-10-03 |
| Summary: | summary |