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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 K021290
Device Name VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
Applicant
VISTA MEDICAL TECHNOLOGIES, INC.
134 FLANDERS RD.
WESTBOROUGH,  MA  01581
Applicant Contact GRAHAM BAILLIE
Correspondent
VISTA MEDICAL TECHNOLOGIES, INC.
134 FLANDERS RD.
WESTBOROUGH,  MA  01581
Correspondent Contact GRAHAM BAILLIE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/23/2002
Decision Date 06/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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