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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 K003893
Device Name VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
Applicant
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Applicant Contact LINDA GUTHRIE
Correspondent
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Correspondent Contact LINDA GUTHRIE
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received12/18/2000
Decision Date 03/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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