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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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ois-2500 diagnostic ultrasound system OPTIMAL IMAGING SYSTEMS, INC. k000415 04/11/2000
bodyguard VITAL SIGNS, INC. k000441 04/11/2000
e3 microprob series of lasers and accessories MARTIN URAM, MD k000192 04/10/2000
digital inflection rigidometer (dir) UROAN XXI ELECTROMEDICINA k000194 04/10/2000
synchron systems alcohol reagent and calibrators BECKMAN COULTER, INC. k000410 04/10/2000
betel powder free latex exam gloves, chlorinated, with protein labeling claim (50 micrograms or less) BETELCARE SDN BHD k000652 04/10/2000
minxray hf70d high frequency portable dental x-ray unit MINXRAY, INC. k000061 04/07/2000
renegade hi-flo microcatheter BOSTON SCIENTIFIC CORP. k000177 04/07/2000
hardydisk ceftriaxone 30mcg HARDY DIAGNOSTICS k000440 04/07/2000
screeners benzodiazepine (bzd) test, drug screen dip benzodiazepine (bzd) test DRUG DETECTION DEVICES, LTD. k000449 04/07/2000

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