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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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cushion-flex tm Life Design Systems, Inc. k843169 08/20/1984
cspi specimen trap (non-sterile) Custom Surgical Products, Inc. k870874 04/19/1988
cryothin™ surgical system and accessories Medinux (Tianjin) Technologies Co., Ltd. k231661 11/27/2023
cr5 cardiac monitor Cardiac Recorders, Ltd. k852887 11/14/1985
counter 700 & hc-700 hemo 0 ref. Hycel, Inc. k771107 07/11/1977
coulter viscometer ii Coulter Electronics, Inc. k883503 09/19/1988
copeland resurfacing humeral heads Biomet Manufacturing, Inc. k010664 04/05/2001
copal ua-512 digital blood pressure monitor Takeda Medical, Inc. k852564 08/19/1985
coopervision acap power drive ultrasonic anterior CooperVision, Inc. k854375 12/27/1985
cool-tec electrodes Seedling Enterprises., LLC k001723 07/19/2000

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