Cleared Traditional

K852893 - VIAL DECANTER (FDA 510(k) Clearance)

K852893 · Advance Medical Designs, Inc. · General Hospital
Sep 1985
Decision
73d
Days
Class 2
Risk

K852893 is an FDA 510(k) clearance for the VIAL DECANTER. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on September 20, 1985, 73 days after receiving the submission on July 9, 1985.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K852893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date September 20, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KPE — Container, I.v.
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5025