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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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picsi sperm selection device BIOCOAT, INC. k052457 04/13/2006
piezotome 2 SATELEC k091331 12/11/2009
pink powder free nitrile examination glove with bubblegum scented, chemotherapy drugs and fentanyl test claim Riverstone Resources Sdn Bhd k220401 04/09/2022
pio root canal indicator NATIONAL PATENT DEVELOPMENT CORP. k822793 10/22/1982
plastazote shoe ALIMED, INC. k801743 08/07/1980
plastic adhesive bandage DYN-A-MED PRODUCTS k802764 11/24/1980
pmc laparoscopic instruments PMC MEDICAL GMBH k101193 10/18/2010
polychloroprene powder-free surgical glove (white) tested for use with chemotherapy drugs; polychloroprene powder-free surgical glove (green) tested for use with chemotherapy drugs PT MEDISAFE TECHNOLOGIES k142190 07/14/2015
polyether urethane material change in neurostimulation leads MEDTRONIC VASCULAR k040568 03/25/2004
porphyrin (ala) disk REMEL CO. k801492 08/13/1980

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