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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 K904070
Device Name COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A
Applicant
Kretztechnik AG
C/O Cone Instruments, Inc.
5201 Naiman Pkwy.
Solon,  OH  44139
Applicant Contact JAY C CONE
Correspondent
Kretztechnik AG
C/O Cone Instruments, Inc.
5201 Naiman Pkwy.
Solon,  OH  44139
Correspondent Contact JAY C CONE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/04/1990
Decision Date 10/09/1992
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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