TOPS DISPOS. INFUSION SET/HEMODIALYSIS— 510(k) K841119

Name: FDA 510(k) clearance K841119
Creator: U.S. Food and Drug Administration
Published: 1984-04-20

Substantially Equivalent

Top Surgical Manufacturers Co.

FDA 510(k) clearance K841119 for TOPS DISPOS. INFUSION SET/HEMODIALYSIS, Substantially Equivalent on 1984-04-20. Applicant: Top Surgical Manufacturers Co.. Device class: 2.

Clearance details

Applicant: Top Surgical Manufacturers Co.
Product code: Code KNZ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1984-03-15
Decision date: 1984-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER1985-01-29
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K842864 — VACCESS FEMORAL CANNULA1984-08-08
K842416 — DUO FLOW CATHETER-MC 541984-07-26
K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL1984-06-25

More clearances from Top Surgical Manufacturers Co.

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K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE1985-01-08
K843415 — TOP HYPODERMIC SYRINGE LUER LOCK1984-12-07
K843313 — TOP DISPOSABLE SPINAL NEEDLE1984-09-19
K843414 — TOP HYPODERMIC SYRINGE PISTON1984-09-07
K841025 — TOP DISPOSABLE INFUSION SET1984-03-30

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