FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DAVRON PROF. SCRUB BRUSH-DRY/STERILE

K Number: K831488 · Decision Jun 8, 1983
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
4
Review Days
29

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Basic Information

Device Name
DAVRON PROF. SCRUB BRUSH-DRY/STERILE
K Number
K831488
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Minnetonka, Inc.
Date Received
May 10, 1983
Decision Date
June 8, 1983
Product Code
GEC
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEC Brush, Scrub, Operating-Room

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Other Clearances by Minnetonka, Inc.

K Number Device Name
K883619 MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
K883566 MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL
K860843 CHECK-UP PLAQUE FIGHTING GUM