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FDA 510(k) Application Details - K971612
Device Classification Name
Bandage, Liquid
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510(K) Number
K971612
Device Name
Bandage, Liquid
Applicant
PROCYTE CORP.
12040 115TH AVENUE NE
SUITE 210
KIRKLAND, WA 98034-6900 US
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Contact
PAUL KETTERIDGE
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Regulation Number
880.5090
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Classification Product Code
KMF
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More FDA Info for this Product Code
Date Received
05/02/1997
Decision Date
03/16/1998
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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