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FDA 510(k)

DEFEND FLUID RESISTANT PLEATED MASK

K-Number: K971130 · 1997-06-27

ApplicantCarl Parker Associates, Inc.
Decision Date1997-06-27
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEFEND FLUID RESISTANT PLEATED MASK is the device name listed in this FDA 510(k) record. The listed applicant is Carl Parker Associates, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971130. 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 DEFEND FLUID RESISTANT PLEATED MASK?

DEFEND FLUID RESISTANT PLEATED MASK is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Carl Parker Associates, Inc.. The 510(k) number is K971130.

When did DEFEND FLUID RESISTANT PLEATED MASK receive FDA 510(k) clearance?

DEFEND FLUID RESISTANT PLEATED MASK received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971130.

Who is the listed applicant for DEFEND FLUID RESISTANT PLEATED MASK?

The FDA 510(k) record lists Carl Parker Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFEND FLUID RESISTANT PLEATED MASK?

The FDA product code for DEFEND FLUID RESISTANT PLEATED MASK is FXX.

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Other records listing Carl Parker Associates, 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.

K962654COMPLEAT SURGICAL MASKK932056DEFEND SELF-SEALING STERILIZATION POUCHK891308STERILE SURGICAL GLOVESK891257DEFEND LATEX EXAMINATION GLOVESK891157DEFEND LATEX EXAMINATION GLOVESK871558DENTAL FACE MASKS, POLYESTER

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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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