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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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insufflation needle, model r65-933 A & A MEDICAL, INC. k000027 04/03/2000
insyte catheter, insyte autoguard catheter BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. k000235 04/05/2000
inter-op metasul hooded and protrusio acetabular inserts SULZER ORTHOPEDICS, INC. k001536 07/27/2000
intercure ltd. respi-low INTERCURE LTD. k000405 05/17/2000
interventional body coil USA INSTRUMENTS, INC. k000437 04/14/2000
invigra male latex condom blue colored and vanilla flavored INDUS MEDICARE LTD. k000040 03/21/2000
invigra male latex condom green colored and mint flavored INDUS MEDICARE LTD. k000038 03/21/2000
invigra male latex condom yellow colored and banana flavored INDUS MEDICARE LTD. k000039 03/21/2000
isobar spinal system ENCORE ORTHOPEDICS, INC. k000425 03/07/2000
isolette infant incubator, model c2hs HILL-ROM AIR-SHIELDS k001242 07/13/2000

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