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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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synthetic absorbable suture Johnson & Johnson International k944937 05/19/1995
systemate creatinine test Em Diagnostic Systems, Inc. k923203 09/09/1992
t-plate anterior fixation system Esm Technologies k051764 07/13/2005
tal pallindrome (tm) symmetric tip dual lumen catheter, mahurkar (r) maxid (tm) dual lumen catheter, palindrome (tm)... Covidien k111372 08/04/2011
tampax c plastic tampons, unscented The Procter & Gamble Co. k110669 06/02/2011
tbg ria Syncor Intl. Corp. k842167 07/09/1984
tbl-abi system Ld Technology, LLC k173696 12/19/2017
tens & ems device Shenzhen Jian Feng Electronic Technology Co., Ltd. k202866 05/19/2021
tens device Western Advanced Technology, Inc. k812138 08/20/1981
the alberta lens sm2, sulfocon b Progressive Optical Research , Ltd. k010454 08/01/2001

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