Cleared Traditional

K880894 - ALLERGIST SYRINGES
(FDA 510(k) Clearance)

K880894 · Abco Dealers, Inc. · General Hospital

Mar 1988

Decision

29d

Days

Class 2

Risk

K880894 is an FDA 510(k) clearance for the ALLERGIST SYRINGES. This device is classified as a Syringe, Piston (Class II — Special Controls, product code FMF).

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 31, 1988, 29 days after receiving the submission on March 2, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K880894 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1988
Decision Date	March 31, 1988
Days to Decision	29 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—