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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K000221
Device Name SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
Applicant
Ge Dec Medical Systems
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact TED L PARROT
Correspondent
Ge Dec Medical Systems
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact Monica Morrison
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received01/24/2000
Decision Date 04/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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