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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K943513
Device Name PS II
Applicant
Washington Biotechnology
P.O. Box 4428
Seattle,  WA  98104
Applicant Contact STEFAN L PASKELL
Correspondent
Washington Biotechnology
P.O. Box 4428
Seattle,  WA  98104
Correspondent Contact STEFAN L PASKELL
Regulation Number866.3110
Classification Product Code
LYR  
Date Received07/20/1994
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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