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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 K081370
Device Name SERIM DISINTEK OPA TEST STRIP
Applicant
Serim Research Corp.
3506 Reedy St.
Elkhart,  IN  46561
Applicant Contact PATRICIA RUPCHOCK
Correspondent
Serim Research Corp.
3506 Reedy St.
Elkhart,  IN  46561
Correspondent Contact PATRICIA RUPCHOCK
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/15/2008
Decision Date 07/11/2008
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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