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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 K981094
Device Name MEDRAD NEUROVASCULAR COIL
Applicant
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact RODNEY J RYLANDS
Correspondent
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Correspondent Contact RODNEY J RYLANDS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/26/1998
Decision Date 06/18/1998
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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