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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 K843182
Device Name MASTER-CHEK BOWIE-DICK TYPE TEST
Applicant
Arvey Corp.
3500 N. Kimball Ave.
Chicago,  IL  60618
Applicant Contact SANCES
Correspondent
Arvey Corp.
3500 N. Kimball Ave.
Chicago,  IL  60618
Correspondent Contact SANCES
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/13/1984
Decision Date 10/09/1984
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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