FDA 510(k) Application Details - K121548

Device Classification Name Arthroscope

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510(K) Number K121548
Device Name Arthroscope
Applicant SPINE VIEW, INC.
48810 Kato Rd. Suite 100E
Fremont, CA 94538 US
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Contact Diana DeGregorio
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 05/25/2012
Decision Date 08/16/2012
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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