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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K063799
Device Name STEAMPLUS STEAM INTEGRATOR
Applicant
Spsmedical Supply Corp.
6789 W. Henrietta Rd.
Rush,  NY  14543
Applicant Contact GARY J SOCOLA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received12/22/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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