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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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hwa (and) silktex powder-free latex examination glove with protein labeling claim (50 microgram or less) Hwa Teh Industrial Sdn. Bhd. k000725 04/05/2000
renaflo ii hf 2000 hemofilter Minntech Corp. k000028 04/04/2000
stela ut46 and bt45/46 straight tined pacing leads, stela uj45 and bj44/45 j-shaped tined pacing leads Ela Medical, Inc. k000029 04/04/2000
suni max Satelec k000049 04/04/2000
insufflation needle, model r65-933 A & A Medical, Inc. k000027 04/03/2000
apple medical one-touch uterine sampler Apple Medical Corp. k000026 03/31/2000
randox albumin Randox Laboratories, Ltd. k000483 03/31/2000
envoy and vista brite tip Cordis Corp. k000715 03/31/2000
unipolar needles Pajunk GmbH k000722 03/31/2000
modification to rta retinal thickness analyzer Talia Technology , Ltd. k000731 03/31/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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