FDA 510(k) Application Details - K991023

Device Classification Name Wrap, Sterilization

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510(K) Number K991023
Device Name Wrap, Sterilization
Applicant CASE MEDICAL, INC.
1900 K STREET, N.W.
WASHINGTON, DC 20006-1108 US
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Contact LARRY R PILOT
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 03/29/1999
Decision Date 01/27/2000
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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