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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K021132
Device Name UNI-PATCH ULTRASOUND COUPLING GEL
Applicant
THE LUDLOW COMPANY LP
TWO LUDLOW PARK DR.
CHICOPEE,  MA  01022
Applicant Contact M. BETH RICE
Correspondent
THE LUDLOW COMPANY LP
TWO LUDLOW PARK DR.
CHICOPEE,  MA  01022
Correspondent Contact M. BETH RICE
Regulation Number892.1570
Classification Product Code
MUI  
Date Received04/09/2002
Decision Date 05/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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