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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 K951624
Device Name ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
Applicant
Argus Medical Co., Inc.
385 S. Lemon Ave.
Suite E-219
Walnut,  CA  91789
Applicant Contact WILLIAM MEYER
Correspondent
Argus Medical Co., Inc.
385 S. Lemon Ave.
Suite E-219
Walnut,  CA  91789
Correspondent Contact WILLIAM MEYER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/07/1995
Decision Date 07/26/1995
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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