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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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otw megalink sds biliary stent system ADVANCED CARDIOVASCULAR SYSTEMS, INC. k000550 03/17/2000
p20 series digital color doppler ultrasound system Sonoscape Medical Corp. k172993 12/05/2017
pacemaker extension cable models 4265,4265a, 4265v, 5265, 5265a, 5265v PACE MEDICAL k002204 10/18/2000
pacemaker lead adaptor model 431 PACESETTER SYSTEMS k802407 10/31/1980
palodent matrices & bitine rings ALVIN MEYER, D.D.S. k801142 08/07/1980
palomar luxir fractional handpiece PALOMAR MEDICAL TECHNOLOGIES, INC. k060069 03/02/2006
panda ires warmer, giraffe warmer GE Healthcare k201628 02/12/2021
pathfinder nxt minimally invasive pedicle screw system ZIMMER SPINE, INC. k132884 11/25/2013
patient examination gloves 3A Glove Sdn. Bhd. k230777 10/06/2023
patient isolator #s-10/d-10 MICROELECTRODES, INC. k820566 03/23/1982

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