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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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insufflation needle, model r65-933 A & A Medical, Inc. k000027 04/03/2000
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
powder-free latex examination gloves with protein content labeling claim (50 micrograms or less) Shasta Asia Partners Gloves Manufacturing CO , Ltd. k000584 04/12/2000
blue max balloon dilatation catheter, maxforce balloon catheter, xxl balloon dilatation cathater, symmetry balloon dila Boston Scientific Corp k000570 04/13/2000
synthes (usa) wrist fusion plates (wfp) Synthes (Usa) k000558 04/14/2000
drg aurica elisa testosterone kit Drg Intl., Inc. k000043 04/17/2000
ge logiq 700 GE Medical Systems k000571 04/18/2000
i-stat model 200 portable clinical analyzer I-Stat Corp. k001154 04/18/2000
tempo aqua angiographic catheter Cordis Corp. k000579 05/03/2000

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