The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Advanced Surgical Solid State Bipolar Coagulator.
| Device ID | K895800 |
| 510k Number | K895800 |
| Device Name: | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | James C Easley |
| Correspondent | James C Easley ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-28 |
| Decision Date | 1990-01-22 |