The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Surgery Brush.
Device ID | K782173 |
510k Number | K782173 |
Device Name: | SURGERY BRUSH |
Classification | Brush, Scrub, Operating-room |
Applicant | DEXIDE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-29 |
Decision Date | 1979-01-10 |