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510(k) K853265

ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 by Geneva Laboratories, Inc.

K853265 is an FDA 510(k) premarket notification submitted by Geneva Laboratories, Inc. for the device "ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543". The FDA issued a decision of Substantially Equivalent on August 26, 1985. Geneva Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1985
Date Received
August 5, 1985
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)
  • K861219 — ACCUPAC CUSTOM SKIN SCRUB KIT (April 15, 1986)
  • 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