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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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concentric balloon guide catheter, model 90031 CONCENTRIC MEDICAL, INC. k010954 10/09/2001
acs: 180 and advia centaur anti-thyroglobulin immunoassays BAYER CORP. k012777 10/22/2001
device modification of enteral feeding sets for gravity and pump use ZEVEX, INC. k012147 11/02/2001
nurvo 9000 endocavitary coils USA INSTRUMENTS, INC. k011683 12/10/2001
ramp myoglobin assay RESPONSE BIOMEDICAL CORP. k012040 12/18/2001
powder free polymer coated latex surgical gloves, sterile (protein labeling claim) WRP ASIA PACIFIC SDN. BHD. k020019 01/23/2002
cosmo tens pf-990 mini digital wireless patch COSMO HEALTH INC. k013507 01/25/2002
sharpoint coated, fast absorbing polyglycolic acid synthetic suture, undyed SURGICAL SPECIALTIES CORP. k014021 01/28/2002
sterilmed reprocessed compression sleeves STERILMED, INC. k012597 02/11/2002
cannabinoids ABBOTT LABORATORIES k013247 03/13/2002

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