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FDA 510(k) Application Details - K990875
Device Classification Name
Dressing, Wound And Burn, Occlusive
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510(K) Number
K990875
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
DERMAPHYLYX, INC.
12106, WEST 75TH LN.
ARVADA, CO 80005-5306 US
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Contact
ANDREW M REED
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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
03/16/1999
Decision Date
05/27/1999
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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