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FDA 510(k) Application Details - K983163
Device Classification Name
Dressing, Wound And Burn, Occlusive
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510(K) Number
K983163
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
COLOPLAST CORP.
1955 WEST OAK CIR.
MARIETTA, GA 30062-2249 US
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Contact
M. SYDNEY LILLY
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Regulation Number
000.0000
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Classification Product Code
MGP
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More FDA Info for this Product Code
Date Received
09/10/1998
Decision Date
12/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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