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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name container, specimen mailer and storage, temperature controlled, sterile
510(k) Number K913967
Device Name DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
Applicant
DOXTECH, INC.
4000 easton dr., #10
bakersfield,  CA  93309
Applicant Contact stanley d ogden
Correspondent
DOXTECH, INC.
4000 easton dr., #10
bakersfield,  CA  93309
Correspondent Contact stanley d ogden
Regulation Number864.3250
Classification Product Code
KDW  
Date Received09/05/1991
Decision Date 10/18/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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