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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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lexur enamel coating-porcelain repair-bonding veneers Dent Zar, Inc. k960600 04/26/1996
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
evita 4 Drager, Inc. k961687 12/13/1996
synthes 7.0/7.3 mm cannulated screws Synthes (Usa) k962011 08/05/1996
acrylic reading and polycarbonate lenses sunglasses Jane Fui Optical Co., Ltd. k962279 08/26/1996
flexiflo low-profile balloon gastrostomy tube Abbott Laboratories k962554 11/07/1997
stryker encore sterilizer Stryker Corp. k962755 03/04/1997

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