Cleared Traditional

K955657 - NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
(FDA 510(k) Clearance)

K955657 · North State Plastics, Inc. · Anesthesiology
Mar 1996
Decision
91d
Days
Class 1
Risk

K955657 is an FDA 510(k) clearance for the NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by North State Plastics, Inc. (Denver, US). The FDA issued a Cleared decision on March 12, 1996, 91 days after receiving the submission on December 12, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K955657 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1995
Decision Date March 12, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYP — Mouthpiece, Breathing
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5620