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FDA 510(k) Application Details - K002078
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K002078
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
PHILLIP LAWIN
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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
07/10/2000
Decision Date
10/02/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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