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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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sterile powdered latex surgeon gloves SUPERMAX GLOVE MANUFACTURING SDN BHD k010198 02/23/2001
sterile piston syringe ABBOTT LABORATORIES k002717 01/08/2001
sterile latex surgical gloves (powdered) with protein content labeling claim (100 micrograms or less) SMART GLOVE CORP. SDN BHD k011066 09/11/2001
sterichek total chlorine reagent strips ENVIRONMENTAL TEST SYSTEMS, INC. k001194 07/11/2000
stela ut46 and bt45/46 straight tined pacing leads, stela uj45 and bj44/45 j-shaped tined pacing leads ELA MEDICAL, INC. k000029 04/04/2000
statsign electrode conductivity gel, graham-field electrode conductivity gel, models 004008, 48-4000 2gf, 48-4000gf CHESTER LABS, INC. k001705 06/29/2000
spiral radius rodding system UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k000009 03/10/2000
spermicidal lubricated male latex condom INNOLATEX SDN. BHD k010178 04/27/2001
sonoace sa 9900 diagnostic ultrasound system MEDISON AMERICA, INC. k002185 08/01/2000
sonoace 600 diagnostic ultrasound system MEDISON AMERICA, INC. k000030 01/19/2000

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