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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 K982916
Device Name MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
Applicant
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact JIM FERGUSON, JR.
Correspondent
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Correspondent Contact JIM FERGUSON, JR.
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/19/1998
Decision Date 10/29/1998
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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