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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|---|---|---|---|
| i.a.s.s., iv set w/air vent & i.a.p.s. w/o airvent | Migada, Ltd. | k853385 |
08/23/1985 |
| peritoneal dialysis stystem and accessories | Microwave Medical Systems, Inc. | k900295 |
11/21/1990 |
| profemur preserve classic stem | Microport Orthopedics, Inc. | k150302 |
04/10/2015 |
| superflab | Mick Radio-Nuclear Instruments, Inc. | k812893 |
12/08/1981 |
| migwang comfort 38 (polymacon) spherical and toric soft contact lens for daily wear (clear, tinted and cosmetic) | Mi Gwang Contact Lens Co., Ltd. | k051477 |
03/10/2006 |
| meticuly patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | k232889 |
04/30/2024 |
| morpheus | Meibach Tech Ltda | k082249 |
12/31/2009 |
| electrosurgical cutting and coagulating device and accessories | Megadyne Medical Products, Inc. | k943055 |
12/21/1994 |
| mega pericardiocentesis kit | Mega Medical, Inc. | k912564 |
09/05/1991 |
| nim standard reinforced emg endotracheal tube; contact reinforced emg endotracheal tube | Medtronic Xomed, Inc. | k230320 |
10/26/2023 |
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