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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 K991303
Device Name VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
Applicant
Vista Medical Technologies, Inc.
134 Flanders Rd.
Westborough,  MA  01581
Applicant Contact VICKI ANASTASI
Correspondent
Vista Medical Technologies, Inc.
134 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact VICKI ANASTASI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/16/1999
Decision Date 07/12/1999
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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