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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827610
Device Name ULTRASOUND AUTO SECTOR CARDIAC MODULE
Applicant
Technicare Corp.
29100 Aurora Rd.
Solon,  OH  44139
Correspondent
Technicare Corp.
29100 Aurora Rd.
Solon,  OH  44139
Date Received06/15/1982
Decision Date 07/20/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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