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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
Sort by PMA Number [0-9]
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510(K)
Number
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Decision
Date
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evita 4 Drager, Inc. k961687 12/13/1996
disposable gas sampling interface kits Marquest Medical Products, Inc. k960972 10/18/1996
domed percutaneous endoscopic gastrostomy(p.e.g.) feeding tube Applied Medical Technologies k961345 09/17/1996
acrylic reading and polycarbonate lenses sunglasses Jane Fui Optical Co., Ltd. k962279 08/26/1996
synthes 7.0/7.3 mm cannulated screws Synthes (Usa) k962011 08/05/1996
vifs Konica Medical Corp. k955583 05/14/1996
lexur enamel coating-porcelain repair-bonding veneers Dent Zar, Inc. k960600 04/26/1996
rdi cardiac insulation pad R D Intl. k960312 04/19/1996
guthrie powderfree latex examination gloves Guthrie Medicare Products (Melaka) Sdn Bhd k954967 04/15/1996
novalens/novawet sphjerical & perception & vanguard multifocal &/or bifocal (rosifocon a) rigid gas permeable contact lr Novavision, Inc. k955900 03/25/1996

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