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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 K910320
Device Name SERIM PERACETIC ACID REAGENT STRIPS
Applicant
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact MICHAEL MCKENNA
Correspondent
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact MICHAEL MCKENNA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received01/24/1991
Decision Date 05/01/1991
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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