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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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sopheia thyroxine eia kit DIAGNOSTIC PRODUCTS CORP. k823751 01/12/1983
various cardiovascular products C.R. BARD, INC. k823357 03/11/1983
stapletac2 bone anchor system AMERICAN MEDICAL SYSTEMS, INC. k000279 03/01/2000
next step powder free latex examination gloves contains 50 mcgm or less of total water extractable protein per gram ANSELL PERRY k000165 03/10/2000
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
urine cannabinoids (thc) screen flex reagent cartridge, catalog no. df 95a DADE BEHRING, INC. k000461 04/06/2000
percutaneous introducer, model 10383-xxx MEDAMICUS, INC. k000824 04/13/2000
cardtel, model nt-100 CARDIAC TELECOMMUNICATIONS k000609 05/23/2000
sulzer orthopedics ms-30 femoral stem SULZER ORTHOPEDICS, INC. k001078 06/23/2000
ksea bipolar coagulating electrodes KARL STORZ ENDOSCOPY k001630 07/19/2000

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