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FDA 510(k) Application Details - K964215
Device Classification Name
Arthroscope
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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