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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K865010
Device Name MICOR
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact HARRY K SCHWILL
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact HARRY K SCHWILL
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/23/1986
Decision Date 07/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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