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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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limb restraint MEDICAL RESTRAINTS, INC. k771630 09/30/1977
impregnated dental floss L.D. CAULK CO. k771400 08/22/1977
phadecode differential factor xa1 assay PHARMASEAL DIV., BAXTER HEALTHCARE CORP. k770942 07/21/1977
micro bi-polar forceps #39-200 EDWARD WECK, INC. k771186 07/15/1977
reagent, t-3 uptake G.D. SEARLE AND CO. k770738 06/22/1977
needle, biopsy, boyd, lung COOK, INC. k770523 06/20/1977
stoma bags w/microporous adhesive HOLLISTER, INC. k770178 02/01/1977
plastic finger cuffs FRED SAMMONS, INC. k761134 12/02/1976
regular and wide skin staples ETHICON, INC. k760734 11/03/1976
bag, post operative lung exercizing blow DYTEK CORP. k760167 08/06/1976

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