UNI-PATCH ULTRASOUND COUPLING GEL


Device Classification Name

media,coupling,ultrasound

510(k) Number K021132
Device Name UNI-PATCH ULTRASOUND COUPLING GEL
Original Applicant
THE LUDLOW COMPANY LP
two ludlow park dr.
chicopee, 
MA 
01022

Original Contact m. beth rice
Regulation Number 892.1570
Classification Product Code
MUI  
Date Received 04/09/2002
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