PROSYS LEG BAG— 510(k) K951945

Name: FDA 510(k) clearance K951945
Creator: U.S. Food and Drug Administration
Published: 1995-05-25

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K951945 for PROSYS LEG BAG, Substantially Equivalent on 1995-05-25. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 1.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code FAQ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-26
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAQ

view all

K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING1996-07-18
K960217 — CPR URINE BAG1996-03-28
K955609 — CONVEEN URINE BAG - STERILE1995-12-29
K953767 — PROSYS BEDSIDE DRAINAGE BAG1995-12-20
K953783 — CONVEEN LEG BAG STRAP1995-09-13

More clearances from Convatec, A Division of E.R. Squibb & Sons

view all

K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING2002-06-21
K990964 — SIGNADRESS DUODERM DRESSING1999-05-18
K984388 — HA ABSORBENT WOUND DRESSING1999-03-03
K980720 — NONWOVEN PAD1998-04-15
K980382 — NON-WOVEN COMPRESS1998-03-09

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