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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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Applicant
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510(K)
Number
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Decision
Date
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bilateral fitting of the branemark bone-anchored hearing aid (baha) system. ENTIFIC MEDICAL SYSTEMS, INC. k011438 07/23/2001
sun-tens palm type r5/compact wireles m2 ems series SUN-RAIN SYSTEM CORP. k011913 10/26/2001
powder free brown latex surgical gloves with protein content labeling claim (50 micrograms or less) WRP ASIA PACIFIC SDN. BHD. k012135 08/01/2001
storz modulith slk lithotripter with multiview option KARL STORZ ENDOSCOPY-AMERICA, INC. k012482 10/16/2001
cooltouch varizoom NEW STAR LASERS, INC. k012982 10/02/2001
p.l.u.s. system (pivot link universal system) SPINEVISION, INC. k013312 02/13/2002
polymer coated powder free latex medical examination gloves with protein labeling claim (50 micrograms or less) MAXTER GLOVE MANUFACTURING SDN BHD k013554 01/17/2002
incare pelvic floor therapy system HOLLISTER, INC. k013612 03/19/2002
irma sl blood analysis system lactate cartridge DIAMETRICS MEDICAL, INC. k013938 01/28/2002
avid-nit nerve stimulation needles AVID N.I.T., INC. k014246 07/16/2002

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