SAFESEAL REUSABLE URINAL SYSTEM— 510(k) K851682

Name: FDA 510(k) clearance K851682
Creator: U.S. Food and Drug Administration
Published: 1985-06-24

Substantially Equivalent

Dbt Medical , Ltd.

FDA 510(k) clearance K851682 for SAFESEAL REUSABLE URINAL SYSTEM, Substantially Equivalent on 1985-06-24. Applicant: Dbt Medical , Ltd.. Device class: 1.

Clearance details

Applicant: Dbt Medical , Ltd.
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1985-04-23
Decision date: 1985-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Witney,0x8 7az, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXJ

view all

K970465 — BOUSER'S URINAL1997-12-18
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

More clearances from Dbt Medical , Ltd.

view all

K851681 — SAFESTRETCH INCONTINENCE SYSTEM1985-06-28
K851678 — OSTOMY BAGS URETHEROSTOMY1985-06-27
K851679 — OSTOMY BAGS COLOSTOMY1985-06-27
K851680 — OSTOMY BAGS ILEOSTOMY1985-06-27

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