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510(k) K822735

SURE-COUNT DISPOSABLE NEEDLE COUNTER by Geneva Laboratories, Inc. — Product Code MMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
September 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • 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)

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