FDA 510(k) Application Details - K955594

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K955594
Device Name Set, I.V. Fluid Transfer
Applicant MCGAW, INC.
2525 MCGAW AVE.
P.O. BOX 19791
IRVINE, CA 92713-9791 US
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Contact JOHN G D'ANGELO
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 12/08/1995
Decision Date 03/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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