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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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510(K)
Number
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Decision
Date
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bioscanner triglycerides test strips POLYMER TECHNOLOGY SYSTEMS, INC. k000586 07/03/2000
shuttle stop ISOTIS NV k000587 05/04/2000
dimension garant l, dimension garant l quick ESPE DENTAL AG k000588 03/30/2000
model 445si-64e quadrature wrist coil IGC-MEDICAL ADVANCES, INC. k000589 03/14/2000
lateral pivot insert ENCORE ORTHOPEDICS, INC. k000590 05/11/2000
dimension penta h, dimension penta h quick ESPE DENTAL AG k000591 03/30/2000
unolok plus infusion set and vaku-8 plus blood collection set MYCO MEDICAL SUPPLIES, INC. k000592 04/12/2001
sonic, model so-100 METRON MEDICAL AUSTRALIA PTY LTD k000593 08/04/2000
locking screw mandibular reconstruction plate STRYKER LEIBINGER k000594 12/08/2000
dimension penta l ESPE DENTAL AG k000595 04/05/2000

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