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FDA 510(k) Application Details - K170216
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K170216
Device Name
Sleeve, Limb, Compressible
Applicant
Tactile Systems Technology, Inc (dba Tactile Medical)
1331 Tyler Street NE, Suite 200
Minneapolis, MN 55413 US
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Contact
Thomas A. Dold
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
01/24/2017
Decision Date
05/26/2017
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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