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510(k) K911745

SIMPLATE PEDIATRIC by Organon Teknika Corp. — Product Code JCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
April 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Bleeding Time
Device Class
Class II
Regulation Number
864.6100
Review Panel
HE
Submission Type

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  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code JCA

  • K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (July 17, 1991)
  • K871318 — Q.I.C. BLEEDING TIME DEVICE (June 10, 1987)
  • K850542 — SURGICUTT - BLEEDING TIME DEVICE (March 1, 1985)
  • K830645 — BLEEDING TIME DEVICE DISPOSABLE (March 17, 1983)
  • K801815 — AUTOLET (October 10, 1980)
  • K761250 — SIMPLATE (March 1, 1977)