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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
Date
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monarch spinal systems DEPUY ACROMED k013294 10/09/2001
smartflow FLORENCE MEDICAL LTD. k012947 10/02/2001
omnicare dental implant system OMNICARE DENTAL IMPLANT CENTER k000035 09/28/2001
premicron nonabsorbable pet surgical suture AESCULAP, INC. k012201 09/19/2001
aquanet, model ec 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION k000031 09/10/2001
jms a.v. fistula needle set accordion type JMS CO., LTD. k002352 09/06/2001
optibond solo plus 3 KERR DENTAL MATERIALS CENTER k011908 09/06/2001
aems v, ems-1000, model ts-140500 and aems vi, ems-1000 plus, model ts-140600 APEX MEDICAL CORP. k002339 08/24/2001
modification to: reaads anti-phosphatidylserine igg/igm semi-quantitative test kit CORGENIX, INC. k012567 08/23/2001
disposable hypodermic needle electrode, model 9013s0421,9013s0431,9013s0441,9013s0451,9013s0461,1013s0421,103s0431 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S k002992 08/15/2001

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