FDA 510(k) Application Details - K023658

Device Classification Name Wrap, Sterilization

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510(K) Number K023658
Device Name Wrap, Sterilization
Applicant CARR METAL PRODUCTS, INC.
6329 WEST WATERVIEW COURT
MCCORDSVILLE, IN 46055-9501 US
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Contact PAUL DRYDEN
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 10/31/2002
Decision Date 03/25/2003
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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