PEDIATRIC DRAIN BAG— 510(k) K896581

Substantially Equivalent

Laytech Medical Co.

FDA 510(k) clearance K896581 for PEDIATRIC DRAIN BAG, Substantially Equivalent on 1990-01-31. Applicant: Laytech Medical Co.. Device class: 2.

Clearance details

Applicant: Laytech Medical Co.
Product code: Code FFH
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-17
Decision date: 1990-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFH

K905016 — PEDIATRIC AND INFANT CATH KITS1990-12-20
K871789 — INTECARE PEDIATRIC URINE COLLECTOR1987-08-10

More clearances from Laytech Medical Co.

K893827 — PEAK FLOW RATE METER1989-08-11

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