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FDA 510(k) Application Details - K193288
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K193288
Device Name
Sleeve, Limb, Compressible
Applicant
Koya, Inc.
357 Tehama Street Ste. 1
San Francisco, CA 94103 US
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Contact
Andy Doraiswamy
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
11/27/2019
Decision Date
06/16/2020
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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