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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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510(K)
Number
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Decision
Date
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programmable hearing system, ite and bte types Audioscience, Inc. k922422 06/10/1992
prizm hearing system, model power bte Audioscience, Inc. k936007 03/04/1994
endosseous implants Attachments Intl., Inc. k904236 11/27/1991
atlantic optical systems optifilter system Atlantic Optical Systems, Inc. k850533 03/21/1985
arthrex fibertak suture anchor Arthrex, Inc. k203268 11/27/2020
integral hemodialysis catheter Arrow Int'L. k040260 03/05/2004
surefire 10 Argen Precious Metals, Inc. k940282 03/04/1994
computer assisted archival tech. physiology stat. Archival Technologies, Inc. k931900 03/11/1994
ultra touch powdered latex examination gloves Ar Alliance Healthcare Sdn. Bhd. k020359 03/06/2002
tracheostomy tube and tube cuff Applied Medical Resources k924660 12/11/1992

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