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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 K961800
FOIA Releasable 510(k) K961800
Device Name HEAD MOUNTED DISPLAY
Applicant
Vista Medical Technologies, Inc.
5451 Avenida Encinas, Suite A
Carlsbad,  CA  92008
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Vista Medical Technologies, Inc.
5451 Avenida Encinas, Suite A
Carlsbad,  CA  92008
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/09/1996
Decision Date 09/11/1996
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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