FDA 510(k) Application Details - K954652

Device Classification Name Arthroscope

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510(K) Number K954652
Device Name Arthroscope
Applicant AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
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Contact MARY ELLEN HOLDEN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 10/10/1995
Decision Date 02/14/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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