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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 K123681
Device Name 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
Applicant
Wipro GE Healthcare Private, Ltd.
122 (Part 1) John F Welch Trdng Centre, Epip, Whitefield Rd.
Bangalore,  IN 560066
Applicant Contact SHASHIDHAR C S
Correspondent
Wipro GE Healthcare Private, Ltd.
122 (Part 1) John F Welch Trdng Centre, Epip, Whitefield Rd.
Bangalore,  IN 560066
Correspondent Contact SHASHIDHAR C S
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/30/2012
Decision Date 02/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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