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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceOLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER
Generic NameSusceptibility test powders, antimicrobial
Regulation Number866.1640
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN50062
Date Received11/24/1969
Decision Date11/24/1969
Reclassified Date05/06/2003
Product Code JTT 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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