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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)
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Decision
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stela ut46 and bt45/46 straight tined pacing leads, stela uj45 and bj44/45 j-shaped tined pacing leads Ela Medical, Inc. k000029 04/04/2000
sterile inhalation water transfer set Intertech Resources, Inc. k882582 09/30/1988
stick Stick Tech , Ltd. k003333 01/04/2001
stick net Stick Tech , Ltd. k003334 01/08/2001
stimuquik 21g x 9cm (3.5”) peripheral nerve block needle, stimuquik echo 21g x 9cm (3.5”) peripheral nerve block needle, stimuquik 21g x 15cm (6”) peripheral nerve block needle, stimuquik echo 21g x 15cm (6”) peripheral nerve block needle, stimuquik 21g x 2.5cm (1”) peripheral nerve block needle Teleflex Medical k173321 04/25/2018
stitchkit Origami Surgical Inc . k221527 02/14/2023
sulzer orthopedics ms-30 femoral stem Sulzer Orthopedics, Inc. k001078 06/23/2000
sun-dreamer suntanning bed Sun-Dream Tanning , Ltd. k862142 06/17/1986
super sheath Togo Medikit Co., Ltd. k141070 01/15/2015
sure check ovulation predictor Chembio Diagnostic Systems, Inc. k010244 05/02/2001

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