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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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Decision
Date
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smart shield non-sterile powder-free peppermint scented green latex examination gloves SHIELD GLOVES MANUFACTURER (M) SDN BHD k000156 02/18/2000
smith & nephew operative hysteroscope, model 7209208; smith & nephew continuous flow sheath, model 8105224 SMITH & NEPHEW, INC. k013870 01/17/2002
solar shoulder offset humeral head HOWMEDICA OSTEONICS CORP. k001419 07/27/2000
sonoace 600 diagnostic ultrasound system MEDISON AMERICA, INC. k000030 01/19/2000
spatouch photoepilation system RADIANCY (ISRAEL) LTD. k020856 06/13/2002
spectrum silicone catheter COOK, INC. k021557 05/30/2003
sperm wash medium, cat# 2003/2005 INVITROCARE, INC. k000989 06/08/2000
spife 2000/3000 lipoprotein; model# 3340, 3341, 3342, 3343 HELENA LABORATORIES k013466 12/21/2001
spiro pro ERICH JAEGER GMBH k000648 03/29/2000
sr ivocron IVOCLAR VIVADENT, INC. k013869 08/28/2002

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