EXTERNAL LEG BAG— 510(k) K901219

Substantially Equivalent

Orion Life Systems, Inc.

FDA 510(k) clearance K901219 for EXTERNAL LEG BAG, Substantially Equivalent on 1990-06-27. Applicant: Orion Life Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orion Life Systems, Inc.
Product code: Code FAQ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-13
Decision date: 1990-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAQ

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 Orion Life Systems, Inc.

K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID1995-01-24
K943828 — STERILE WATER FOR IRRIGATION1994-11-21
K943829 — PRE-FILLED SYSRINGE W/STERILE WATER1994-11-21
K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION1994-11-21
K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER1994-11-21

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