FDA 510(k) Application Details - K011083

Device Classification Name Arthroscope

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510(K) Number K011083
Device Name Arthroscope
Applicant ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE, CA 94085-2936 US
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Contact BRUCE PROTHRO
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 04/10/2001
Decision Date 06/28/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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