FDA 510(k) Application Details - K971337

Device Classification Name Bandage, Liquid

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510(K) Number K971337
Device Name Bandage, Liquid
Applicant RYNEL LTD, INC.
ROUTE 27
BOOTHBAY, ME 04537 US
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Contact TIM THOMSON
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 04/10/1997
Decision Date 07/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K971337


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