Cleared Traditional

K913455 - OXYGEN MASKS 82400 & 82405
(FDA 510(k) Clearance)

K913455 · Specialty Packaging Producs, Inc. · Anesthesiology device

Oct 1991

Decision

61d

Days

Class 1

Risk

K913455 is an FDA 510(k) clearance for the OXYGEN MASKS 82400 & 82405. 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 2, 1991, 61 days after receiving the submission on August 2, 1991.

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

Submission Details

510(k) Number	K913455 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 02, 1991
Decision Date	October 02, 1991
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement