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FDA 510(k) Application Details - K991202
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K991202
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
COLOPLAST CORP.
1940 COMMERCE DR.
P.O. BOX 8300
NORTH MANKATO, MN 56003-8300 US
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Contact
HARVEY M ARBIT
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MGQ
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More FDA Info for this Product Code
Date Received
03/22/1999
Decision Date
06/04/1999
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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