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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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510(K)
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Decision
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o-perm 30 OPTICAL POLYMER RESEARCH, INC. k002703 11/21/2000
automatic blood pressure monitor with intellisense, model hem-757 OMRON HEALTHCARE, INC. k001670 06/30/2000
ultra compact wrist blood pressure monitor with intellisense, model hem-630 OMRON HEALTHCARE, INC. k001671 06/30/2000
omnicare dental implant system OMNICARE DENTAL IMPLANT CENTER k000035 09/28/2001
disposable microkeratome blades-pe OASIS MEDICAL, INC. k001176 09/21/2000
numalink NUMA, INC. k002724 11/17/2000
electrosurgical electrode family, model 20-2 needle balloon catheter, model 40-4 needle balloon catheter, model 60-6 nee NOVASYS MEDICAL, INC. k001150 06/29/2000
electrosurgical electrode family NOVASYS MEDICAL, INC. k001151 06/27/2000
model 2500, palmsat hand held pulse oximeter, model 2500 NONIN MEDICAL, INC. k002690 10/11/2000
branemark novum NOBEL BIOCARE UAS INC k000018 03/30/2000

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