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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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510(K)
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Decision
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serum total protein reagent set Medical Specialties, Inc. k841069 05/01/1984
finger mitt restraint Medical Restraints, Inc. k771632 09/28/1977
mxact total prosthesis offcenter, mxact total prosthesis center and mxact pro total prosthesis kit MED-EL Elektromedizinische Geräte GmbH k241269 01/17/2025
cathra gram positive screen Mct Medical, Inc. k874606 05/06/1988
button infuser Markwell Medical Institute, Inc. k831063 08/24/1983
body boot Mark-Clark k940723 09/06/1994
marco standard lensmeters 101,201 Marco Ophthalmic, Inc. k930441 07/06/1993
the uric acid reagent set Macomb Biotechnology, Inc. k871902 06/03/1987
dmi series 90 examination table M.D. Intl., Inc. k894788 09/08/1989
blood kit, sexual assault kit Lynn Peavey Co. k945245 02/01/1995

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