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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K992698
Device Name STENTOR, PAGEVIEW
Applicant
Stentor, Inc.
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
Stentor, Inc.
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received08/11/1999
Decision Date 10/25/1999
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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