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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|---|---|---|---|
| medient middle turbinate implant; (single pack-1 pair, four pack-4 pair) | ENTRIGUE SURGICAL, INC. | k130354 |
05/29/2013 |
| medical surgical mask (black mask, level 1 and level 3) | Guangdong Kingfa Sci.&Tech. Co., Ltd. | k213450 |
04/05/2022 |
| medcare powder-free blue nitrile patient examination gloves | Dongguan Grinvald Technology Co., Ltd. | k211808 |
03/04/2022 |
| maxfit ii dental implant system | Taiwan Implant Technology Company, Ltd. | k151588 |
04/25/2016 |
| masterloc stem | MEDACTA INTERNATIONAL | k160289 |
05/20/2016 |
| markley threaded wire | ALMORE INTL., INC. | k830773 |
04/28/1983 |
| male natural rubber latex condom (with coloring and flavoring) | KAREX INDUSTRIES SDN BHD | k070830 |
05/08/2007 |
| male natural rubber latex condom | NRS GLOBAL PARTNERS | k050244 |
04/08/2005 |
| magnum nail | ROBERT REID INC. | k093089 |
11/13/2009 |
| lysing reagent | OMEGA MEDICAL DIAGNOSTICS | k832182 |
08/12/1983 |
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