The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Sterile Surgical Scrub Brush.
Device ID | K874653 |
510k Number | K874653 |
Device Name: | STERILE SURGICAL SCRUB BRUSH |
Classification | Brush, Scrub, Operating-room |
Applicant | SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
Contact | Christal O Fisher |
Correspondent | Christal O Fisher SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
Product Code | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1987-12-30 |