Cleared Traditional

K100640 - 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 (FDA 510(k) Clearance)

K100640 · B.Braun Medical, Inc. · General Hospital

Jul 2010

Decision

139d

Days

Class 2

Risk

K100640 is an FDA 510(k) clearance for the 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on July 22, 2010, 139 days after receiving the submission on March 5, 2010.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K100640 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 2010
Decision Date	July 22, 2010
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF