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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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kronner low profile scope holder KRONNER PROTOTYPES, INC. k000663 05/02/2000
laxtex powdered examination glove with protein labeling claim (100 micrograms or less) KOSSAN LATEX INDUSTRIES (M) SDN. BHD. k001557 06/09/2000
track 1.0 & 1.5 mm systems-tissue regeneration by alveolar callus distraction KLS-MARTIN L.P. k002152 10/10/2000
gem posterior stabilized total knee system KINAMED, INC. k010101 05/17/2001
olympus endoscopic flushing pump model ofp-1 KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. k000948 05/12/2000
audioscreener oae KEDLY, INC. k000184 02/11/2000
brothers powder-free vinyl examination gloves KAOHSIUNG BROTHERS PRODUCTS CORP. k000058 03/10/2000
cement it! universal c&b JENERIC/PENTRON, INC. k000173 02/29/2000
correct plus JENERIC/PENTRON, INC. k001218 07/05/2000
opc 3g all-ceramic system, core and overlay porcelains JENERIC/PENTRON, INC. k994435 02/10/2000

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