FDA 510(k) Application Details - K040612

Device Classification Name Arthroscope

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510(K) Number K040612
Device Name Arthroscope
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
3 HASADNAOT ST.
HERZLIYA 46728 IL
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Contact YAEL RUBIN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 03/08/2004
Decision Date 06/17/2004
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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