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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 K122978
Device Name SANICLAVE 102, MODEL RS-SC-102
Applicant
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
17319 LAKE BLVD.
SHAFER,  MN  55074
Applicant Contact ISAAC ERICKSON
Correspondent
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
17319 LAKE BLVD.
SHAFER,  MN  55074
Correspondent Contact ISAAC ERICKSON
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/26/2012
Decision Date 05/23/2013
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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