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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|---|---|---|---|
| endosseous implants | Attachments Intl., Inc. | k904236 |
11/27/1991 |
| energized drug container system | Abbott Laboratories | k934119 |
06/09/1994 |
| enflu 18 (enflufocon a) daily wear contact lens | Contamac, Ltd. | k171575 |
10/24/2017 |
| enzymatic glucose reagent (hexokinase) | Trace Scientific , Ltd. | k860724 |
04/07/1986 |
| enzyme immunoassay anti-centromere antibody test | Helix Diagnostics, Inc. | k000489 |
04/05/2000 |
| espin system | Nlt Spine, Ltd. | k133061 |
11/27/2013 |
| estech easyflow cannula with guidewire | Endoscopic Technologies, Inc. D/B/A Estech | k091542 |
10/20/2009 |
| ever-more powder-free latex examination gloves, blue color | Ever-More Latex Products Sdn Bhd | k023522 |
11/29/2002 |
| extreme 4x4-x8 power wheelchair | Vestil Manufacturing Corp. | k090350 |
04/10/2009 |
| f&p vitera mask full face a model (small, medium, large), f&p vitera mask full face sleep lab model (small, medium, large) | Fisher & Paykel Healthcare, Ltd. | k190713 |
10/11/2019 |
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