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510(k) K881213

GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER by Geneva Laboratories, Inc. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Geneva Laboratories, Inc.

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  • 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)
  • 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)

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  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)