FDA 510(k) Application Details - K962075

Device Classification Name Arthroscope

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510(K) Number K962075
Device Name Arthroscope
Applicant HENKE SASS WOLF OF AMERICA, INC.
SOROCO INDUSTRIAL PARK
ROUTE 131
SOUTHBRIDGE, MA 01550 US
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Contact JOHN M SMITH
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 05/28/1996
Decision Date 01/17/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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