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FDA 510(k)

PRIMED SHOE COVERS, PRIMED HEAD COVERS

K-Number: K971076 · 1998-01-13

ApplicantPrimeline Medical Products, Inc.
Decision Date1998-01-13
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIMED SHOE COVERS, PRIMED HEAD COVERS is the device name listed in this FDA 510(k) record. The listed applicant is Primeline Medical Products, Inc.. It received FDA 510(k) clearance on 1998-01-13 under 510(k) number K971076. 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 PRIMED SHOE COVERS, PRIMED HEAD COVERS?

PRIMED SHOE COVERS, PRIMED HEAD COVERS is a medical device that received FDA 510(k) clearance on 1998-01-13. The listed applicant is Primeline Medical Products, Inc.. The 510(k) number is K971076.

When did PRIMED SHOE COVERS, PRIMED HEAD COVERS receive FDA 510(k) clearance?

PRIMED SHOE COVERS, PRIMED HEAD COVERS received FDA 510(k) clearance on 1998-01-13, under 510(k) number K971076.

Who is the listed applicant for PRIMED SHOE COVERS, PRIMED HEAD COVERS?

The FDA 510(k) record lists Primeline Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED SHOE COVERS, PRIMED HEAD COVERS?

The FDA product code for PRIMED SHOE COVERS, PRIMED HEAD COVERS is FXP.

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Other records listing Primeline Medical Products, Inc. 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.

K023266PRIMAGARD SURGICAL GOWNSK023117PRIMAGARD SURGICAL GOWNSK022868PRIMAGARD SURGICAL EQUIPMENT DRAPESK021864PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)K021076PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRMK011789PROCEDURE MASKS: PM4-301 AND PM4-304

View all 9 devices →

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.

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.K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.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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