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FDA 510(k) Application Details - K971337
Device Classification Name
Bandage, Liquid
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.5090
More FDA Info for this Regulation Number
Classification Product Code
KMF
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More FDA Info for this Product Code
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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