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FDA 510(k) Application Details - K040649
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K040649
Device Name
Sleeve, Limb, Compressible
Applicant
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact
GAIL CHRISTIE
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/2004
Decision Date
07/15/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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