The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Sterile Scrubby Scrub Brush.
Device ID | K875033 |
510k Number | K875033 |
Device Name: | STERILE SCRUBBY SCRUB BRUSH |
Classification | Brush, Scrub, Operating-room |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Donna Plante |
Correspondent | Donna Plante MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-07 |
Decision Date | 1988-02-19 |