Cleared Traditional

COMFORT-Q SUBCUTANEOUS INJECTION SETS

K946170 · B. Braun of America, Inc. · General Hospital

Nov 1995

Decision

319d

Days

Class 2

Risk

About This 510(k) Submission

K946170 is an FDA 510(k) clearance for the COMFORT-Q SUBCUTANEOUS INJECTION SETS, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 3, 1995, 319 days after receiving the submission on December 19, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K946170 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1994
Decision Date	November 03, 1995
Days to Decision	319 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200