The following data is part of a premarket notification filed by S.t.s Instruments with the FDA for Hemostat, Surgical (various Types).
Device ID | K920883 |
510k Number | K920883 |
Device Name: | HEMOSTAT, SURGICAL (VARIOUS TYPES) |
Classification | Hemostat, Surgical |
Applicant | S.T.S INSTRUMENTS 766 E. 9TH ST. Brooklyn, NY 11230 |
Contact | Riaz Saleem |
Correspondent | Riaz Saleem S.T.S INSTRUMENTS 766 E. 9TH ST. Brooklyn, NY 11230 |
Product Code | EMD |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-26 |
Decision Date | 1992-03-13 |