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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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body-worn hearing aid, model 787pp Danavox, Inc. k781595 09/27/1978
therapy appar. 422 interferential General Theraphysical, Inc. k781319 10/03/1978
calcitonin 125 Cambridge Nuclear Radiopharmaceutical k781909 01/10/1979
shaker, model sh-510 Sysmex Corp. k790027 02/08/1979
reprodent Premier Dental Products Co. k790325 03/02/1979
lombard dowell broth mediumw/th reonine Anaerobe Systems k790620 04/23/1979
juhn tym-tap Xomed, Inc. k790915 06/27/1979
para-7 Streck Laboratories, Inc. k791227 08/03/1979
bovie csv hand control adapter Sybron Corp. k791767 10/11/1979
usher's marlex tubular mesh Davol, Inc. k792281 11/27/1979

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