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FDA 510(k) Application Details - K964398
Device Classification Name
Dressing, Wound And Burn, Occlusive
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510(K) Number
K964398
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
POLYMEDICA INDUSTRIES, INC.
581 CONFERENCE PLACE
GOLDEN, CO 80401 US
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Contact
JULIE CHAFFEE
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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
11/04/1996
Decision Date
10/24/1997
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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