The following data is part of a premarket notification filed by Seamless Hospital Products Co. with the FDA for Brush, Scrub, Operating Room.
Device ID | K823061 |
510k Number | K823061 |
Device Name: | BRUSH, SCRUB, OPERATING ROOM |
Classification | Brush, Scrub, Operating-room |
Applicant | SEAMLESS HOSPITAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-18 |
Decision Date | 1982-11-05 |