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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K953888
Device Name TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE
Applicant
VISTA MEDICAL TECHNOLOGIES, INC.
725 SOUTHGATE COURT
OCEANSIDE,  CA  92057
Applicant Contact KENT RICHARDS
Correspondent
VISTA MEDICAL TECHNOLOGIES, INC.
725 SOUTHGATE COURT
OCEANSIDE,  CA  92057
Correspondent Contact KENT RICHARDS
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/17/1995
Decision Date 10/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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