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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 K983401
Device Name FRAMEWAVE WEB
Applicant
ML STRATEGIES, INC.
ONE FINANCIAL CENTER
BOSTON,  MA  02111
Applicant Contact ALLAN M GREEN
Correspondent
ML STRATEGIES, INC.
ONE FINANCIAL CENTER
BOSTON,  MA  02111
Correspondent Contact ALLAN M GREEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/1998
Decision Date 12/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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