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FDA 510(k) Application Details - K992221
Device Classification Name
Dressing, Wound And Burn, Occlusive
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510(K) Number
K992221
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
WESTAIM BIOMEDICAL, INC.
ONE HAMPTON RD.
SUITE 302
EXETER, NH 03833 US
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Contact
SALLY L MAHER
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Regulation Number
000.0000
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Classification Product Code
MGP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/1999
Decision Date
06/07/2000
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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