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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K101858
Device Name PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
Applicant
Shanghai Chenguang Medical Technologies Co, Ltd.
Bldg. 8, Lane 1199, Jidi Rd.
Shanghai,  CN 201107
Applicant Contact JIE HUANG
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/02/2010
Decision Date 07/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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