H-H SHUNT PASSERS— 510(k) K841553

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K841553 for H-H SHUNT PASSERS, Substantially Equivalent on 1984-05-14. Applicant: Holter-Hausner Intl.. Device class: 1.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code GYK
Device class: Class 1
Regulation: 21 CFR 882.4545
Advisory panel: Neurology
Date received: 1984-04-16
Decision date: 1984-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYK

K962761 — REIGEL TUNNELING DEVICE1996-10-11
K934391 — V/P AND L/P CATHETER PASSERS1993-11-19
K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER1993-09-10
K932273 — CORDIS TUNNELER1993-08-23
K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE1989-10-31

More clearances from Holter-Hausner Intl.

K875287 — H-H FLUSHING RESERVOIR1988-07-14
K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG1988-01-19
K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC1987-09-28
K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC1987-09-28
K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC1987-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.