FDA 510(k) Application Details - K193288

Device Classification Name Sleeve, Limb, Compressible

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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
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Regulation Number 870.5800

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Classification Product Code JOW
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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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