The following data is part of a premarket notification filed by Debusk Knitting Mills, Div. Deroyal Industries with the FDA for Electrosurgical Cutting & Coagulation Device & Accessories.
| Device ID | K961097 |
| 510k Number | K961097 |
| Device Name: | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 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 | 1996-03-19 |
| Decision Date | 1996-06-03 |
| Summary: | summary |