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510(k) Premarket Notification Database

Device Classification Name pad, eye
510(k) NumberK904896
Device NameEYE PAD
Applicant
ULTI-MED INTL., INC.
1688 glen ellyn rd.
glendale heights,  IL  60139
Contactdavid insco
Regulation Number878.4440
Classification Product Code
HMP
Date Received10/30/1990
Decision Date 12/05/1990
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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