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FDA 510(k) Application Details - K973592
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K973592
Device Name
Sleeve, Limb, Compressible
Applicant
A. STEIN - REGULATORY AFFAIRS CONSULTING
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact
AHAVA STEIN
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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
09/22/1997
Decision Date
05/20/1999
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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