Cleared Traditional

K913383 - OXYGEN MASKS 81420, 81421, 81471 & 81461
(FDA 510(k) Clearance)

K913383 · Specialty Packaging Producs, Inc. · Anesthesiology device

Oct 1991

Decision

81d

Days

Class 1

Risk

K913383 is an FDA 510(k) clearance for the OXYGEN MASKS 81420, 81421, 81471 & 81461. This device is classified as a Mask, Oxygen (Class I - General Controls, product code BYG).

Submitted by Specialty Packaging Producs, Inc. (El Paso, US). The FDA issued a Cleared decision on October 18, 1991, 81 days after receiving the submission on July 29, 1991.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K913383 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 1991
Decision Date	October 18, 1991
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement