The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Sedlacek Handle.
| Device ID | K926179 |
| 510k Number | K926179 |
| Device Name: | SEDLACEK HANDLE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | SIMPSON/BASYE, INC. 889 S. MATLACK ST. West Chester, PA 19382 |
| Contact | Robert A Basye |
| Correspondent | Robert A Basye SIMPSON/BASYE, INC. 889 S. MATLACK ST. West Chester, PA 19382 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-08 |
| Decision Date | 1994-03-25 |