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510(k) K831488

DAVRON PROF. SCRUB BRUSH-DRY/STERILE by Minnetonka, Inc. — Product Code GEC

K831488 is an FDA 510(k) premarket notification submitted by Minnetonka, Inc. for the device "DAVRON PROF. SCRUB BRUSH-DRY/STERILE". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. Minnetonka, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
May 10, 1983
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

Other clearances by Minnetonka, Inc.

  • K883566 — MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL (September 1, 1989)
  • K883619 — MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL (September 1, 1989)
  • K860843 — CHECK-UP PLAQUE FIGHTING GUM (May 21, 1986)

Other clearances for product code GEC

  • K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (July 7, 1997)
  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)

FDA data resources