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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 K031089
Device Name GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
Applicant
W. L. Gore & Associates, Inc.
750 Ott'S Chapel Rd.
Newark,  DE  19713
Applicant Contact TRACY DE VAN WOLF
Correspondent
W. L. Gore & Associates, Inc.
750 Ott'S Chapel Rd.
Newark,  DE  19713
Correspondent Contact TRACY DE VAN WOLF
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/07/2003
Decision Date 05/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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