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FDA 510(k) Application Details - K981636
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K981636
Device Name
Arthroscope
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
Other 510(k) Applications for this Company
Contact
CAROL A WEIDEMAN
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
05/08/1998
Decision Date
08/20/1998
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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