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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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diamond (mammographic x-ray system) INSTRUMENTARIUM IMAGING, INC. k000976 06/01/2000
delta 32 and delta 32 tact INSTRUMENTARIUM IMAGING, INC. k002472 11/29/2000
friendly light er:yag pulsed laser INNOTECH USA, INC. k000023 11/06/2000
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
invigra male latex condom blue colored and vanilla flavored INDUS MEDICARE LTD. k000040 03/21/2000
continuum knee system-ps femoral components- porous, model xx-yyy-zzzzz IMPLEX CORP. k001307 05/23/2000
model 473si-64e quadrature lower extremity coil IGC-MEDICAL ADVANCES, INC. k001312 06/20/2000
posi-link ICU MEDICAL, INC. k000472 05/10/2000
model 5000 multiplace hyperbaric therapy HYPERTEC, INC. k002794 12/06/2000

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