FDA 510(k) Application Details - K955678

Device Classification Name Wrap, Sterilization

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510(K) Number K955678
Device Name Wrap, Sterilization
Applicant CONTOUR FABRICATORS OF FLORIDA, INC.
1247 FLORIDA AVE.
PALM HARBOR, FL 34683 US
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Contact PATRICK J LAMB
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 12/14/1995
Decision Date 02/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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