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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 K990919
Device Name STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
Applicant
VISUALIZATION TECHNOLOGY, INC.
200 RESEARCH DR.
WILMINGTON,  MA  01887
Applicant Contact PETER OHANIAN
Correspondent
VISUALIZATION TECHNOLOGY, INC.
200 RESEARCH DR.
WILMINGTON,  MA  01887
Correspondent Contact PETER OHANIAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/1999
Decision Date 04/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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