Cleared Traditional

K884156 - HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
(FDA 510(k) Clearance)

K884156 · Sechrist Industries, Inc. · General Hospital

Nov 1988

Decision

41d

Days

Class 2

Risk

K884156 is an FDA 510(k) clearance for the HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on November 14, 1988, 41 days after receiving the submission on October 4, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K884156 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 1988
Decision Date	November 14, 1988
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—