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FDA 510(k) Application Details - K964238
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K964238
Device Name
Sleeve, Limb, Compressible
Applicant
AIRCAST, INC.
92 RIVER RD.
SUMMIT, NJ 07902 US
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Contact
STEPHEN L KENNEY
Other 510(k) Applications for this Contact
Regulation Number
870.5800
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Classification Product Code
JOW
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More FDA Info for this Product Code
Date Received
10/23/1996
Decision Date
09/08/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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