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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K935580
Device Name PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
Applicant
PRECISE OPTICS
239 SOUTH FEHR WAY
BAY SHORE,  NY  11706
Applicant Contact RON HANNINGTON
Correspondent
PRECISE OPTICS
239 SOUTH FEHR WAY
BAY SHORE,  NY  11706
Correspondent Contact RON HANNINGTON
Regulation Number892.1650
Classification Product Code
OXO  
Date Received11/18/1993
Decision Date 03/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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