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FDA 510(k) Application Details - K952495
Device Classification Name
Orthopedic Manual Surgical Instrument
More FDA Info for this Device
510(K) Number
K952495
Device Name
Orthopedic Manual Surgical Instrument
Applicant
ORTHOPEDIC SYSTEMS, INC.
30031 AHERN AVE.
UNION CITY, CA 94587-1234 US
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Contact
STEVE LAMB
Other 510(k) Applications for this Contact
Regulation Number
888.4540
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Classification Product Code
LXH
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More FDA Info for this Product Code
Date Received
05/30/1995
Decision Date
01/22/1996
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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