Cleared Traditional

K902713 - ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS
(FDA 510(k) Clearance)

K902713 · Diemolding Corp. · Anesthesiology

Jul 1990

Decision

35d

Days

Class 2

Risk

K902713 is an FDA 510(k) clearance for the ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).

Submitted by Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on July 25, 1990, 35 days after receiving the submission on June 20, 1990.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K902713 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 1990
Decision Date	July 25, 1990
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—