FDA 510(k) Application Details - K202659

Device Classification Name Arthroscope

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510(K) Number K202659
Device Name Arthroscope
Applicant Stryker
5900 Optical Court
San Jose, CA 95138 US
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Contact Christie Samsa
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/14/2020
Decision Date 12/01/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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