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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 K961628
Device Name MINI FLEX COIL
Applicant
W.L. Gore & Associates, Inc.
4747 E. Beautiful Ln.
Phoenix,  AZ  85044
Applicant Contact KEN DAVIS
Correspondent
W.L. Gore & Associates, Inc.
4747 E. Beautiful Ln.
Phoenix,  AZ  85044
Correspondent Contact KEN DAVIS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/26/1996
Decision Date 09/05/1996
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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