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FDA 510(k)

CONTURA DISPOS. SURG. FACE MASK

K-Number: K813078 · 1981-12-18

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1981-12-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTURA DISPOS. SURG. FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is American Convertors Div., American Pharmaseal. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813078. 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 CONTURA DISPOS. SURG. FACE MASK?

CONTURA DISPOS. SURG. FACE MASK is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K813078.

When did CONTURA DISPOS. SURG. FACE MASK receive FDA 510(k) clearance?

CONTURA DISPOS. SURG. FACE MASK received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813078.

Who is the listed applicant for CONTURA DISPOS. SURG. FACE MASK?

The FDA 510(k) record lists American Convertors Div., American Pharmaseal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTURA DISPOS. SURG. FACE MASK?

The FDA product code for CONTURA DISPOS. SURG. FACE MASK is FXX.

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Other records listing American Convertors Div., American Pharmaseal 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.

K840957ANTIMICROBIAL INCISE DRAPEK832137CONVERTORS FLASH STERILIZING TRAYK830786DISIMETRIC RELEASE OF INSTRANETICS RADK820994ABSORB FURN SHEETK813419COMFORT CUSHION DRY BURN PAD IIIK813296CONVERTORS STERILE DISP. LAP SPONGE II

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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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