BOUSER'S URINAL— 510(k) K970465

Substantially Equivalent

General Polymers

FDA 510(k) clearance K970465 for BOUSER'S URINAL, Substantially Equivalent on 1997-12-18. Applicant: General Polymers. Device class: 1.

Clearance details

Applicant: General Polymers
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-07
Decision date: 1997-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Recent devices under product code EXJ

K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)1997-07-31
K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER1997-04-22
K963265 — PROSYS SAMEC LA1996-10-25
K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16
K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER1996-07-15

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