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FDA 510(k) Application Details - K010951
Device Classification Name
Dressing, Wound And Burn, Occlusive
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510(K) Number
K010951
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
ISLAND DRESSING, LLC.
300 CORPORATE PKWY.
SUITE 116N
AMHERST, NY 14226 US
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Contact
JOHN A DOBOS
Other 510(k) Applications for this Contact
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
03/28/2001
Decision Date
06/11/2001
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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