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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
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exam room astroglide (professional market), target lubricating jelly (otc consumer market) BIOFILM, INC. k003867 03/09/2001
sensititre susceptibility plates-additional antimicrobics TREK DIAGNOSTIC SYSTEMS, INC. k003868 02/27/2001
thromborel s DADE BEHRING, INC. k003870 02/20/2001
laparoscopic hand port APPLIED MEDICAL RESOURCES CORP. k003871 05/31/2001
guthrie prime powdered latex examination gloves with protein content labeling claim (200 micrograms or less) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD k003872 01/23/2001
mentor self-cath closed system MENTOR CORP. k003873 03/29/2001
cbc-4k hematology control R & D SYSTEMS, INC. k003874 01/12/2001
ti-replica hip stem DEPUY ORTHOPAEDICS, INC. k003875 03/01/2001
us sensor #cg-930p; toco sensor cg-940p CARD GUARD SCIENTIFIC SURVIVAL, LTD. k003876 07/09/2001
mar cor services semper pure ro machine MAR COR SERVICES, INC. k003877 06/22/2001

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