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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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deluxe adjustable height ultrasound table Biodan Medical Systems, Ltd. k922604 10/20/1992
e.z. port(tm) radiation therapy skin markers I.Z.I. Corp. k922287 10/16/1992
sunrunner te-777 Pride Health Care, Inc. k923193 07/17/1992
elisa tube tsh test Bio Clinic Co. k921958 07/02/1992
augustine fiberoptic laryngoscope Augustine Medical, Inc. k915161 05/29/1992
multiple sterile gauze bandage rolls, vari sizes Kerma Medical Products, Inc. k915821 05/29/1992
seamless latex patient exam gloves Digitcare Corp. k920700 05/11/1992
flowers medial malar implant Implantech Associates, Inc. k921582 05/06/1992
sidestream drug nebulizer Medic-Aid , Ltd. k914152 05/05/1992
gx-c cephalometer Gendex Corp. k920189 04/28/1992

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