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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 K102363
Device Name SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
Applicant
SPS MEDICAL SUPPLY CORP.
6789 WEST HENRIETTA RD.
RUSH,  NY  14543
Applicant Contact GARY J SOCOLA
Correspondent
SPS MEDICAL SUPPLY CORP.
6789 WEST HENRIETTA RD.
RUSH,  NY  14543
Correspondent Contact GARY J SOCOLA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/20/2010
Decision Date 01/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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