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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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pbn hystero-salpingography catheter set MEDICAL DEVICE TECHNOLOGIES, INC. k000433 06/16/2000
pc ecg 1200 NORAV MEDICAL LTD. k000404 11/22/2000
pc flow + SPIROMETRICS MEDICAL EQUIPMENT CO. k001528 01/18/2001
pdt dosecalculator, model 80000 RETINALABS.COM k000418 10/24/2000
penile constrictor ring BASIC SOLUTIONS, LLC. k001859 01/11/2001
periform perineometric probe, model 8300 NEEN DESIGN LTD. k002617 04/05/2001
peripheral arterial tonometer-pat 1000rd device ITAMAR MEDICAL (C.M.) 1997 LTD. k001852 02/21/2001
peripherally inserted central catheter UTAH MEDICAL PRODUCTS, INC. k001874 09/25/2000
pico smokerlyzer, model ec-50 BEDFONT SCIENTIFIC LTD. k000962 04/20/2000
pinnacle acetabular system DEPUY ORTHOPAEDICS, INC. k001534 06/12/2000

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