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FDA 510(k) Application Details - K103247
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K103247
Device Name
Sleeve, Limb, Compressible
Applicant
THERMOTEK, INC.
1200 LAKESIDE PARKWAY
#200
FLOWER MOUND, TX 75028 US
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Contact
NIRAN BALACHANDRAN
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
11/03/2010
Decision Date
12/10/2010
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
Y
Expedited Review
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