FDA 510(k) Application Details - K023025

Device Classification Name Wrap, Sterilization

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510(K) Number K023025
Device Name Wrap, Sterilization
Applicant GRANTON MEDICAL LTD.
PO BOX 4341
CROFTON, MD 21114 US
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Contact E. J. SMITH
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 09/11/2002
Decision Date 03/04/2003
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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