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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K051639
Device Name AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM
Applicant
AS SOFTWARE, INC.
80 SOUTH WOODLAND STREET
ENGLEWOOD,  NJ  07631
Applicant Contact KIM A NATHANSON
Correspondent
AS SOFTWARE, INC.
80 SOUTH WOODLAND STREET
ENGLEWOOD,  NJ  07631
Correspondent Contact KIM A NATHANSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/20/2005
Decision Date 08/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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