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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K905402
Device Name ANTIGENZ CHLAMYDIA
Applicant
Northumbria Biologicals , Ltd.
Nelson Industrial Estate
Cramlington,  GB NE23 9BL
Applicant Contact CITRINI
Correspondent
Northumbria Biologicals , Ltd.
Nelson Industrial Estate
Cramlington,  GB NE23 9BL
Correspondent Contact CITRINI
Regulation Number882.5880
Classification Product Code
GZB  
Date Received12/03/1990
Decision Date 03/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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