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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 K944903
Device Name HP-FAST
Applicant
Gi Supply
423n. 21st St.
Camp Hill,  PA  17011
Applicant Contact FRANK JACKSON
Correspondent
Gi Supply
423n. 21st St.
Camp Hill,  PA  17011
Correspondent Contact FRANK JACKSON
Regulation Number866.3110
Classification Product Code
LYR  
Date Received10/04/1994
Decision Date 04/20/1995
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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