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FDA 510(k)

PROCEDURE MASKS: PM4-301 AND PM4-304

K-Number: K011789 · 2001-06-22

ApplicantPrimeline Medical Products, Inc.
Decision Date2001-06-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROCEDURE MASKS: PM4-301 AND PM4-304 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 2001-06-22 under 510(k) number K011789. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCEDURE MASKS: PM4-301 AND PM4-304?

PROCEDURE MASKS: PM4-301 AND PM4-304 is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Primeline Medical Products, Inc.. The 510(k) number is K011789.

When did PROCEDURE MASKS: PM4-301 AND PM4-304 receive FDA 510(k) clearance?

PROCEDURE MASKS: PM4-301 AND PM4-304 received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011789.

Who is the listed applicant for PROCEDURE MASKS: PM4-301 AND PM4-304?

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 PROCEDURE MASKS: PM4-301 AND PM4-304?

The FDA product code for PROCEDURE MASKS: PM4-301 AND PM4-304 is FXX.

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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; PRMK001951PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306

View all 9 devices →

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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