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FDA 510(k)

MULTIPLE SURGICAL MASK

K-Number: K822481 · 1982-09-17

ApplicantSurgilite Intl., Inc.
Decision Date1982-09-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIPLE SURGICAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Surgilite Intl., Inc.. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822481. 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 MULTIPLE SURGICAL MASK?

MULTIPLE SURGICAL MASK is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Surgilite Intl., Inc.. The 510(k) number is K822481.

When did MULTIPLE SURGICAL MASK receive FDA 510(k) clearance?

MULTIPLE SURGICAL MASK received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822481.

Who is the listed applicant for MULTIPLE SURGICAL MASK?

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

What is the FDA product code for MULTIPLE SURGICAL MASK?

The FDA product code for MULTIPLE SURGICAL 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 Surgilite Intl., 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.

K823671NO-GAUZE LAPAROTOMY SPONGEK822482SURGILITE NON-WOVEN WRAPK822483MULTIPLE SCRUB SUITK771531LAPAROTOMY SPONGES

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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