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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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htf-hepes INVITROCARE, INC. k000939 05/04/2000
human serum albumin (hsa) INVITROCARE, INC. k000940 05/04/2000
fotomaster HAMILTON THORNE RESEARCH k000380 05/03/2000
einstein processing and review workstation GE MEDICAL SYSTEMS F.I. HAIFA k000395 05/03/2000
powderfree latex surgeon's gloves with protien labeling claim (50 mocrograms or less FITCO DIPPED PRODUCTS PVT. LTD k000896 05/03/2000
modification to steathstation treatment guidance platform MEDTRONIC SURGICAL NAVIGATION k001153 05/03/2000
atac pak cholesterol reagent and atac callibrator kits ELAN HOLDINGS, INC. k000900 05/02/2000
opti-free express lens drops ALCON UNIVERSAL, LTD. k000385 04/28/2000
sterile latex powdered patient examination gloves FITCO DIPPED PRODUCTS PVT. LTD k000891 04/28/2000
powder-free latex examination glove sterile with optional protein labeling claim (50 micrograms or less) FITCO DIPPED PRODUCTS PVT. LTD k001216 04/28/2000

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