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FDA 510(k) Application Details - K990368
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
More FDA Info for this Device
510(K) Number
K990368
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
200 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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Contact
ADRIENNE MCNALLY
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
02/08/1999
Decision Date
03/26/1999
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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