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510(k) K911996

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION by International Technidyne Corp. — Product Code JCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
April 22, 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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Other clearances for product code JCA

  • K911745 — SIMPLATE PEDIATRIC (August 9, 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)