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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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sigma's calcium procedure no. 587 Sigma Diagnostics, Inc. k871152 06/12/1987
silverseal orthotic component with x-static Noble Fiber Technologies, Inc. k051256 07/21/2005
sim medium Acumedia Manufacturers, Inc. k811330 05/29/1981
single size tendon spacer Medist International k000019 03/29/2000
single use nebulizer, adjust. air- Airlife, Inc. k830895 04/28/1983
slimming treatment device Beijing Honkon Technologies Co., Ltd. k161892 03/02/2017
slt venous fiber delivery systems, model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 Surgical Laser Technologies, Inc. k023624 01/27/2003
smith & nephew profix total knee system Smith & Nephew, Inc. k030623 05/22/2003
solarcare alanine aminotransferase micro-plate assay Solarcare, Inc. k941497 05/24/1994
spec model m-31 Source Production & Equipment Co., Inc. k090366 04/22/2009

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