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FDA 510(k)

EARLOOP PROCEDURE MASK

K-Number: K034015 · 2004-02-20

ApplicantMedipack Medical Packaging Mfg. Co.
Decision Date2004-02-20
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EARLOOP PROCEDURE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Medipack Medical Packaging Mfg. Co.. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K034015. 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 EARLOOP PROCEDURE MASK?

EARLOOP PROCEDURE MASK is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Medipack Medical Packaging Mfg. Co.. The 510(k) number is K034015.

When did EARLOOP PROCEDURE MASK receive FDA 510(k) clearance?

EARLOOP PROCEDURE MASK received FDA 510(k) clearance on 2004-02-20, under 510(k) number K034015.

Who is the listed applicant for EARLOOP PROCEDURE MASK?

The FDA 510(k) record lists Medipack Medical Packaging Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARLOOP PROCEDURE MASK?

The FDA product code for EARLOOP PROCEDURE MASK is FXX.

Related Clinical Trials

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.

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Other records listing Medipack Medical Packaging Mfg. Co. 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.

K993764MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH

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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