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FDA 510(k) Application Details - K954652
Device Classification Name
Arthroscope
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.1100
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Classification Product Code
HRX
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More FDA Info for this Product Code
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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