Cleared Traditional

K893791 - BREATHING MOUTHPIECE
(FDA 510(k) Clearance)

K893791 · Diemolding Corp. · Anesthesiology

Jun 1989

Decision

32d

Days

Class 1

Risk

K893791 is an FDA 510(k) clearance for the BREATHING MOUTHPIECE, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on June 23, 1989, 32 days after receiving the submission on May 22, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number	K893791 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 1989
Decision Date	June 23, 1989
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—