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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 K871938
Device Name VISION CARE/PHAKOSYSTEMS ECHORULE
Applicant
Phakosystems, Inc.
490 Champagne Dr.
Downsview M3j 2t9,  CA
Applicant Contact KEITH L CARTER
Correspondent
Phakosystems, Inc.
490 Champagne Dr.
Downsview M3j 2t9,  CA
Correspondent Contact KEITH L CARTER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/18/1987
Decision Date 11/23/1987
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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