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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 K964675
Device Name H.PYLORI CONTROLS
Applicant
Pyramid Biological Corp.
6454 Van Nuys Blvd., Suite 111
Van Nuys,  CA  91401
Applicant Contact JEANETTE R PORRETTA
Correspondent
Pyramid Biological Corp.
6454 Van Nuys Blvd., Suite 111
Van Nuys,  CA  91401
Correspondent Contact JEANETTE R PORRETTA
Regulation Number866.3110
Classification Product Code
LYR  
Date Received11/21/1996
Decision Date 01/27/1997
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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