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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 K111453
Device Name STEAM DOT BLU PROCESS INDICATOR
Applicant
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact ANDREW SHARAVARA
Correspondent
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact ANDREW SHARAVARA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/25/2011
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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