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FDA 510(k) Application Details - K963623
Device Classification Name
Dressing, Wound And Burn, Occlusive
More FDA Info for this Device
510(K) Number
K963623
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
POLYMEDICA INDUSTRIES, INC.
581 CONFERENCE PL.
GOLDEN, CO 80401 US
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Contact
ANDREW M REED
Other 510(k) Applications for this Contact
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
09/11/1996
Decision Date
10/25/1996
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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