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510(k) K861219

ACCUPAC CUSTOM SKIN SCRUB KIT by Geneva Laboratories, Inc.

K861219 is an FDA 510(k) premarket notification submitted by Geneva Laboratories, Inc. for the device "ACCUPAC CUSTOM SKIN SCRUB KIT". The FDA issued a decision of Substantially Equivalent on April 15, 1986. Geneva Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1986
Date Received
April 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Geneva Laboratories, Inc.

  • K881217 — GENT-L-KARE STERILE URINARY LEG BAG (July 29, 1988)
  • K881213 — GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (July 28, 1988)
  • K881218 — GENT-L-KARE CLEANSING ENEMA SET (July 28, 1988)
  • K881216 — GENT-L-KARE VAGINAL IRRIGATION SET (June 7, 1988)
  • K861308 — ACCUPAC CUSTOM PACK KERLIX SQUARES (May 2, 1986)
  • K853265 — ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 (August 26, 1985)
  • K843206 — COOK COUNTY HOSPITAL DRESSING CHANGE SET (May 24, 1985)
  • K844255 — GENT-L-KARE STERILE I.V. START KIT (December 19, 1984)
  • K843090 — UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM (December 4, 1984)
  • K830725 — GENT-L-SPEC DISPOS. VAGINAL SPECULUM (April 27, 1983)

FDA data resources