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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, high-voltage, x-ray, diagnostic
510(k) Number K892943
Device Name MULTI PULSE POWER UNIT GENERATOR
Applicant
GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY KROGER
Correspondent
GE MEDICAL SYSTEMS
PO BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY KROGER
Regulation Number892.1700
Classification Product Code
IZO  
Date Received04/21/1989
Decision Date 05/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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