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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 K834353
Device Name OK FLASH STERILIZATION INDICATOR
Applicant
PROPPER MFG. CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PROPPER MFG. CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received12/13/1983
Decision Date 03/19/1984
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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