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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 K970369
FOIA Releasable 510(k) K970369
Device Name VISTA MINI CAMERA SYSTEM
Applicant
Oktas
134 Flanders Rd.
Westborough,  MA  01581
Applicant Contact MARTIN NEWMAN
Correspondent
Oktas
134 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact MARTIN NEWMAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/31/1997
Decision Date 04/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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