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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 K964014
Device Name KENLOR H. PYLORI CONTROL SERUM
Applicant
Kenlor Industries, Inc.
1560 E. Edinger Ave.,
Suite A-1
Santa Ana,  CA  92705
Applicant Contact KAMALES SOM
Correspondent
Kenlor Industries, Inc.
1560 E. Edinger Ave.,
Suite A-1
Santa Ana,  CA  92705
Correspondent Contact KAMALES SOM
Regulation Number866.3110
Classification Product Code
LYR  
Date Received10/07/1996
Decision Date 03/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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