Cleared Traditional

K033739 - PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
(FDA 510(k) Clearance)

K033739 · Physician Industries, Inc. · General Hospital

Jul 2004

Decision

227d

Days

Class 2

Risk

K033739 is an FDA 510(k) clearance for the PHYSICIAN INDUSTRIES' DURAMETER SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Physician Industries, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 12, 2004, 227 days after receiving the submission on November 28, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K033739 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2003
Decision Date	July 12, 2004
Days to Decision	227 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF