FDA 510(k) Application Details - K960194

Device Classification Name Arthroscope

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510(K) Number K960194
Device Name Arthroscope
Applicant MYELOTEC, INC.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK, NY 11021 US
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Contact CAROLANN KOTULA
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 01/16/1996
Decision Date 09/04/1996
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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