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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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magic lite sq specific ige immunoassay system Ciba Corning Diagnostics Corp. k914959 08/20/1992
maclee/boin medica sterile needle/syringe 20ml/cc Mac Lee Medical Products k864781 12/29/1986
mac 5000 ecg analysis system General Electric Medical Systems Information Techn k014108 01/10/2002
ma012 aluminum wheelchair, ms019 steel wheelchair Sichuan Ast Medical Equipment Co., Ltd. k231750 08/15/2023
m2424a sonos 5500/4500 diagnostic ultrasound system, version b.2. 21330a transducer Agilent Technologies, Inc. k002470 09/08/2000
m.w.p. wrist prosthesis Protek, Inc. k872502 07/23/1987
lumboperitoneal shunt system Phoenix Biomedical Corp. k002476 11/09/2000
lubrigel personal lubricant Sheffield Laboratories, Div. of Faria Limited, LLC k001077 08/02/2000
lsi solutions flexible suture placement device and accessories product Lsi Solutions k011016 04/27/2001
lpc-plus acetabular cup Plus Orthopedics k003274 04/06/2001

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