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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Test Isoniazid
510(k) Number K962615
Device Name TUMORLOCALIZER MRI
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Correspondent Contact FRANK FERGUSON
Classification Product Code
MIG  
Date Received07/03/1996
Decision Date 03/19/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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