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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K955282
Device Name THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
Applicant
Thermogenesis Corp.
11431 Sunrise Gold Circle
Suite A
Rancho Cordova,  CA  95742
Applicant Contact PHILIP COELHO
Correspondent
Thermogenesis Corp.
11431 Sunrise Gold Circle
Suite A
Rancho Cordova,  CA  95742
Correspondent Contact PHILIP COELHO
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/16/1995
Decision Date 05/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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