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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 K962321
Device Name ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
Applicant
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Applicant Contact CHERYL L SHEA
Correspondent
ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2936
Correspondent Contact CHERYL L SHEA
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received06/17/1996
Decision Date 07/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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