Cleared Traditional

K852777 - BAG DECANTER (FDA 510(k) Clearance)

K852777 · Advance Medical Designs, Inc. · General Hospital
Aug 1985
Decision
46d
Days
Class 2
Risk

K852777 is an FDA 510(k) clearance for the BAG 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 August 16, 1985, 46 days after receiving the submission on July 1, 1985.

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

Submission Details

510(k) Number K852777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date August 16, 1985
Days to Decision 46 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