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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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Decision
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wristwatch bpm blood pressure monitor, model kp-6120 K-JUMP HEALTH CO., LTD. k002665 03/19/2001
vidas total prostate specific antigen (tpsa), model 30 428 BIOMERIEUX, INC. k010550 04/24/2001
opc oxygen conserving regulator, model ahg 1968, lin-7005, mdl-7609, mem-7612, opc-830 WESTERN ENT. k010747 05/16/2001
jas calcium (arsenazo) reagent JAS Diagnostics, Inc. k011441 07/09/2001
cysto-urethroscopes e-line existing of: sheaths, obturators, inserts, attchements, and forceps model 8650, 8652, 8660 RICHARD WOLF MEDICAL INSTRUMENTS CORP. k011496 08/10/2001
model 6491 unipolar pediatric temporary pacing lead MEDTRONIC VASCULAR k012454 08/14/2001
ortelius 800 ORTHOSCAN LTD. k011827 08/28/2001
huanqiu and super (two brands) sterile acupuncture needle for single use ACUSUPPLY, INC. k011242 09/11/2001
trillium bio disposable blood flow probe (models dp38t & fp38p) MEDTRONIC PERFUSION SYSTEMS k012747 09/14/2001
rapidia 3D MED CO., LTD. k012290 09/28/2001

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