MOSS(R) STEEL BREAKAWAY(R) INTRODUCER— 510(k) K945480

Name: FDA 510(k) clearance K945480
Creator: U.S. Food and Drug Administration
Published: 1995-08-28

Substantially Equivalent

Harry A. Schlakman

FDA 510(k) clearance K945480 for MOSS(R) STEEL BREAKAWAY(R) INTRODUCER, Substantially Equivalent on 1995-08-28. Applicant: Harry A. Schlakman. Device class: 2.

Clearance details

Applicant: Harry A. Schlakman
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-08
Decision date: 1995-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOB

view all

K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set2024-11-01
K181097 — Cook Cystostomy Catheter Set2019-01-18
K182709 — One-Step Suprapubic Introducer2018-12-26
K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set2018-10-30
K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET2014-01-17

More clearances from Harry A. Schlakman

view all

K951122 — CAPITOL URINE DRUG SCREEN COLLECTION KIT1995-05-05

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