Plastic Mouth Barrier Hsv-I

FDA 510(k) K853266 · Westmark Enterprises, Inc.

Substantially Equivalent

510(k) numberK853266

Submission

Device name
Plastic Mouth Barrier Hsv-I
Applicant
Westmark Enterprises, Inc.
Skokie, IL, US
Received
August 5, 1985
Decision date
October 29, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYP – Mouthpiece, Breathing
Device class
Class I (low risk)
Regulation
21 CFR 868.5620
Specialty
Anesthesiology

Other 510(k)s with product code BYP

510(k)DeviceApplicantDecision
K955657North State Plastics Respiratory MouthpieceBYP · Traditional North State Plastics, Inc.03/12/1996SE
K944512Truzone PFM Disposable MouthpieceBYP · Traditional Monaghan Medical Corp.11/02/1994SE
K893791Breathing MouthpieceBYP · Traditional Diemolding Corp.06/23/1989SE
K872037AerochamberBYP · Traditional Monaghan Medical Corp.07/24/1987SE
K865093Safe-T-Shield MouthpieceBYP · Traditional Medi Nuclear Corp., Inc.01/15/1987SE
K863049Inhalation AidBYP · Traditional Boehringer Ingelheim Pharmaceuticals, Inc.10/15/1986SE
K862788MP-4400 Mouthpiece-Flange SealBYP · Traditional Medipart Jerry Alexander08/01/1986SE
K853575Medipart Mouthpiece MP-1010BYP · Traditional Medipart Jerry Alexander10/29/1985SE
K853574Medipart Dispos. Mouthpiece W/22MM O.D. MP-4411BYP · Traditional Medipart Jerry Alexander10/29/1985SE
K853572Medipart Dispos. Mouthpiece W/2MM I.D. MP-4410BYP · Traditional Medipart Jerry Alexander10/29/1985SE

More from Medipart Jerry Alexander

510(k)DeviceDecision
K871403Modified C.P.R. MicroshieldCAE · Traditional 05/04/1987SE
K860780Plastic Mouth Barrier Hcv-ECAE · Traditional 04/02/1986SE

Questions and answers

When was Plastic Mouth Barrier Hsv-I cleared by the FDA?

Plastic Mouth Barrier Hsv-I (K853266) received a 510(k) decision of Substantially Equivalent on October 29, 1985, 85 days after the submission was received.

What is the product code of K853266?

The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.