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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K950943
Device Name ULTRA EASE
Applicant
Lectec Corp.
10701 Red Circle Dr.
Minnetonka,  MN  55343
Applicant Contact JULL R KRALL
Correspondent
Lectec Corp.
10701 Red Circle Dr.
Minnetonka,  MN  55343
Correspondent Contact JULL R KRALL
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/16/1995
Decision Date 03/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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