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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827378
Device Name DIAGNOSTIC X-RAY HV GENERATOR
Applicant
Technicare Corp.
29100 Aurora Rd.
Solon,  OH  44139
Correspondent
Technicare Corp.
29100 Aurora Rd.
Solon,  OH  44139
Date Received04/20/1982
Decision Date 05/19/1982
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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