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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K880081
Device Name VISION CARE/PHAKOSYSTEMS ECHOPACH
Applicant
Phakosystems, Inc.
522 Champagne Dr.
Downsview, Ontario
Canada,  CA M3J 2T9
Applicant Contact KEITH L CARTER
Correspondent
Phakosystems, Inc.
522 Champagne Dr.
Downsview, Ontario
Canada,  CA M3J 2T9
Correspondent Contact KEITH L CARTER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/11/1988
Decision Date 03/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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