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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|---|---|---|---|
| probe cover | Narco Air-Shields | k810474 |
03/31/1981 |
| verigene cftr nucleic acid test and verigene cftr polyt nucleic acid test | Nanosphere, Inc. | k083294 |
07/24/2009 |
| electric wheelchair (model h) | Nanjing E-Take Medical Apparatus Co., Ltd. | k242989 |
12/31/2024 |
| neuro pulse ii | Nagata Engineering Co. | k853836 |
12/09/1985 |
| cannulas | Myocure, Inc. | k880346 |
05/03/1988 |
| ipl hair removal device (m8011, m8012, m8013, m8015, m8021, m8022, m8023, m8025, m7011, m7012, m7021, m7023) | Mustech Electronics Co., Limited | k250131 |
03/19/2025 |
| hrw-42 wrist array coil for 1.0 tesla | Mri Devices Corp. | k001713 |
06/14/2000 |
| biofeedback device access. pi1,2,3,4,5/light bar | Moe | k884849 |
03/23/1989 |
| muscle master (bipolar stimulator) | Modern Systems Technology, Inc. | k862685 |
11/25/1986 |
| renaflo ii hf 2000 hemofilter | Minntech Corp. | k000028 |
04/04/2000 |
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