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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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powder free nitrile gloves St Future International Limited k213448 06/06/2022
durex play massage gel lubricant SSL AMERICAS, INC. k063385 03/10/2008
sleepright prorx custom dental guard Splintek, Inc. k193577 06/01/2020
cadence peek cemeent restrictor SPINAL CONCEPTS, INC. k023647 11/27/2002
model sr-130-d portable digital x-ray system SOURCE-RAY, INC. k043062 12/13/2004
qps (quantitative perfusion spect), qgs (quantitative gated spect) SMV AMERICA k003358 01/19/2001
portex tuohy epidural needle 17g, portex tuohy epidural needle 18g SMITHS MEDICAL ASD, INC. k090261 05/01/2009
afghan external fixator SMITH & NEPHEW, INC. k092002 12/10/2009
smith & nephew healicoil pk suture anchor SMITH & NEPHEW, INC. k113294 01/20/2012
distal elbow plating system Skeletal Dynamics, LLC k171590 06/27/2017

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