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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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tms 1000 temp. monitor & probes GICS PHARMACEUTICALS k800849 05/08/1980
oticon earette hearing aid #e17 hc OTICON CORP. k801002 05/28/1980
libco sunglasses LIBCO EYEWEAR, INC. k801196 05/28/1980
eca cream reformulation VANARAY LABORATORIES, INC. k801383 06/17/1980
sapcrill thermodetect breast scanner dev CALIFORNIA CARDIAC SYSTEMS, INC. k801573 09/09/1980
micro-processor unit #a3600ac GENERAL ELECTRIC CO. k801762 08/27/1980
argyle compact chest drainage system SHERWOOD MEDICAL CO. k801979 09/16/1980
aquasonic 100 ultrasound trans. gel, PARKER LABORATORIES, INC. k802146 10/10/1980
regional intravenous anesthesia kit STANCO MEDICAL, INC. k802290 10/17/1980
estriol-squibb ria kit E. R. SQUIBB & SONS, INC. k802455 10/31/1980

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