FDA 510(k) Application Details - K964215

Device Classification Name Arthroscope

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510(K) Number K964215
Device Name Arthroscope
Applicant SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD, MA 02048 US
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Contact TEDD GOSIAN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 10/22/1996
Decision Date 12/20/1996
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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