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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 K942081
Device Name ENVISION ARTHROSCOPY SYSTEM
Applicant
ENVISION SURGICAL SYSTEM, INC.
1047 ELWELL COURT
PALO ALTO,  CA  94303
Applicant Contact PHIL OLSEN
Correspondent
ENVISION SURGICAL SYSTEM, INC.
1047 ELWELL COURT
PALO ALTO,  CA  94303
Correspondent Contact PHIL OLSEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/29/1994
Decision Date 11/09/1994
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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