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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 K000691
Device Name VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
Applicant
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Applicant Contact JENNIFER BRENNAN
Correspondent
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Correspondent Contact JENNIFER BRENNAN
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received02/29/2000
Decision Date 05/04/2000
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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