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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 K923211
Device Name DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE
Applicant
Zeiss Humphrey System
2992 Alvarado St.
P.O. Box 5400
San Leandro,  CA  94577
Applicant Contact BERRY DODD
Correspondent
Zeiss Humphrey System
2992 Alvarado St.
P.O. Box 5400
San Leandro,  CA  94577
Correspondent Contact BERRY DODD
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/01/1992
Decision Date 11/08/1993
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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