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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K950297
Device Name ARGUS ENDOSCOPIC PLASTIC SURGERY 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 Number876.1500
Classification Product Code
GCJ  
Date Received01/25/1995
Decision Date 03/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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