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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 K053017
Device Name MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
Applicant
INVIVO CORPORATION
N27 W23676 PAUL RD.
PEWAUKEE,  WI  53072
Applicant Contact THOMAS SCHUBERT
Correspondent
INVIVO CORPORATION
N27 W23676 PAUL RD.
PEWAUKEE,  WI  53072
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/26/2005
Decision Date 11/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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