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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K003198
Device Name VULCAN TAC PROBES, MODEL 911XXX
Applicant
ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MENLO PARK,  CA  94025
Applicant Contact LARAINE PANGELINA
Correspondent
ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MENLO PARK,  CA  94025
Correspondent Contact LARAINE PANGELINA
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received10/12/2000
Decision Date 08/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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