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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 K082352
Device Name SERIM DISINTEK OPA TEST STRIP
Applicant
Serim Research Corp.
3506 Reedy Dr.
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact PATRICIA A RUPCHOCK
Correspondent
Serim Research Corp.
3506 Reedy Dr.
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact PATRICIA A RUPCHOCK
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/16/2008
Decision Date 09/25/2008
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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