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FDA 510(k) Application Details - K003198
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K003198
Device Name
Arthroscope
Applicant
ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MENLO PARK, CA 94025 US
Other 510(k) Applications for this Company
Contact
LARAINE PANGELINA
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
10/12/2000
Decision Date
08/29/2001
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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