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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
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at home drug test, model 9063 PHAMATECH k994237 12/30/1999
k-y brand warming ultragel personal lubricant PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC k040340 04/28/2004
convey guiding catheter PENDRACARE INTERNATIONAL, B.V. k120585 08/08/2012
aquamax (polymacon) disposable soft (hydrophilic) contact lenses Pegavision Corporation k123973 04/23/2013
fluorilaq PASCAL CO., INC. k030488 05/02/2003
resin tooth bonding agent PARKELL, INC. k994302 02/07/2000
palomar slp 2000 PALOMAR MEDICAL TECHNOLOGIES, INC. k994225 05/18/2000
model 120 PALCO LABS, INC. k994372 04/28/2000
ultima five PAIN MANAGEMENT TECHNOLOGIES k083494 01/06/2009
cardnav PAIEON, INC. k120282 12/10/2012

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