510(k) K844411

SCRUB MATE DRY STERILE SCRUB BRUSH by American Sterilizer Co. — Product Code GEC

K844411 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "SCRUB MATE DRY STERILE SCRUB BRUSH". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
November 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Scrub, Operating-Room
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type