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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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vital shield gold powder free latex examination gloves with protein content labeling claim (50 micrograms or less) SGMP CO., LTD. k000391 04/12/2000
modification to: sipap infant nasal cpap circuit SENSORMEDICS CORP. k012034 07/24/2001
gel mark biopsy site marker, models mkooo1, mk0004, mk0007 SENORX, INC. k000060 03/27/2000
senoj implant system SENOJ BIOCARE, INC. k000889 04/27/2001
multifunction endoscopic instrument SEEDLING ENTERPRISES. LLC. k012033 09/20/2001
scipro(tm) flexible stone dislodger and retrieval set SCION CARDIOVASCULAR, INC. k001563 11/22/2000
suni max SATELEC k000049 04/04/2000
flocath RUSCH INTL. k000070 02/18/2000
craft duo-vac suction unit and craft suction unit ROCKET MEDICAL PLC k000394 02/29/2000
embryon gift transfer catheters/sets ROCKET MEDICAL PLC k000656 03/09/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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