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 |