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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
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pro.duct catheter, model cth03 PRO.DUCT HEALTH, INC. k000135 04/10/2000
aquanet, model ec 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION k000031 09/10/2001
premier ultrasonic scaler and inserts PREMIER DENTAL PRODUCTS CO. k010195 04/17/2001
pvs 1400 guide wite with hydrophilic coating PRECISION VASCULAR SYSTEMS, INC. k002707 11/08/2000
sinuscope and baccessories POLLUX ENDOSCOPY, INC. k002214 11/21/2000
modification to liquid glucose (hexokinase) reagent set POINTE SCIENTIFIC, INC. k002199 11/20/2000
seragard vascular access patch PLATINUM SERVICES, INC. k001175 09/18/2000
pm 2002 proline/aec PLANMECA OY k000163 04/18/2000
dimax 2 PLANMECA OY k000771 05/03/2000
pioneer surgical technology extended gtr, model 501-601 PIONEER SURGICAL TECHNOLOGY k000734 05/05/2000

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