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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Chilling
510(k) Number K900419
Device Name CRYOTRON-UL30
Applicant
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Applicant Contact ERNEST J HENLEY,PHD
Correspondent
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Correspondent Contact ERNEST J HENLEY,PHD
Regulation Number890.5940
Classification Product Code
IMF  
Date Received01/30/1990
Decision Date 02/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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