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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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7d surgical system - drill guide 7D Surgical Inc. k210555 03/23/2021
a&d medical ua-651 digital blood pressure monitor A & D CO., LTD. k141160 10/07/2014
a1 glove powder free latex patient examination gloves with protein content labeling claim (contains 50 micrograms per dm2 of glove or less of water extractable protein) A1 GLOVE SDN BHD k153744 08/04/2016
astra-vac AB ASTRA k782115 02/01/1979
hydron burn disposable dispenser set ABBOTT LABORATORIES k780616 04/19/1978
ivex-hp pediatric extension set-sl ABBOTT LABORATORIES k821013 07/30/1982
gemstar infusion pump system, 7 therapy, 6 therapy & pain management ABBOTT LABORATORIES INC k023062 09/30/2002
voyager nc coronary dilatation catheter and nc trek rx coronary dilatation catheter ABBOTT VASCULAR-CARDIAC THERAPIES k103153 12/30/2010
aneroid sphymomanometer ABCO DEALERS, INC. k792355 12/05/1979
sorbact wound dressing ABIGO MEDICAL AB k063059 04/19/2007

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