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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K140736
Device Name STERISAFE HP TABLE-TOP STEAM STERILIZER
Applicant
Milton E Pedrazzi D.D.S., Inc.
6501 Crown Blvd., Suite 102
San Jose,  CA  95120
Applicant Contact MILTON E PEDRAZZI DDS
Correspondent
Milton E Pedrazzi D.D.S., Inc.
6501 Crown Blvd., Suite 102
San Jose,  CA  95120
Correspondent Contact MILTON E PEDRAZZI DDS
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/24/2014
Decision Date 01/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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