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510(k) K955554

HEMO-VALVE by North American Instrument Corp. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1996
Date Received
December 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type

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  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K904275 — MORSE BALLOON INFLATION DEVICE (January 3, 1991)
  • K903606 — GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER (September 27, 1990)

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