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FDA 510(k)

PHARMA-PLAST SINGLE USE OVERSHOES

K-Number: K843475 · 1984-10-31

ApplicantZimmar Consulting , Ltd.
Decision Date1984-10-31
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHARMA-PLAST SINGLE USE OVERSHOES is the device name listed in this FDA 510(k) record. The listed applicant is Zimmar Consulting , Ltd.. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K843475. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMA-PLAST SINGLE USE OVERSHOES?

PHARMA-PLAST SINGLE USE OVERSHOES is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Zimmar Consulting , Ltd.. The 510(k) number is K843475.

When did PHARMA-PLAST SINGLE USE OVERSHOES receive FDA 510(k) clearance?

PHARMA-PLAST SINGLE USE OVERSHOES received FDA 510(k) clearance on 1984-10-31, under 510(k) number K843475.

Who is the listed applicant for PHARMA-PLAST SINGLE USE OVERSHOES?

The FDA 510(k) record lists Zimmar Consulting , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMA-PLAST SINGLE USE OVERSHOES?

The FDA product code for PHARMA-PLAST SINGLE USE OVERSHOES is FXP.

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Other records listing Zimmar Consulting , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K860322CLINISET INFUSION SETK843478PHARMA-PLAST URIDROP-URIDOMEK843477PHARMA-PLAST RECTAL TIPK843468PHARMA-PLAST SUCTION SET TYPE YANKAUERK843467PHARMA-PLAST NASAL OXYGEN CANNULAK843466PHARMA-PLAST OXYGEN CATHETER

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Related Devices (Code: FXP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952897NIOMED SHOE COVERSAmerasia Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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