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FDA 510(k)

SANG-A PETROLATUM GAUZE USP STERILE

K-Number: K843035 · 1984-09-20

ApplicantTech-Cons Ltd., Intl.
Decision Date1984-09-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SANG-A PETROLATUM GAUZE USP STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Cons Ltd., Intl.. It received FDA 510(k) clearance on 1984-09-20 under 510(k) number K843035. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANG-A PETROLATUM GAUZE USP STERILE?

SANG-A PETROLATUM GAUZE USP STERILE is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Tech-Cons Ltd., Intl.. The 510(k) number is K843035.

When did SANG-A PETROLATUM GAUZE USP STERILE receive FDA 510(k) clearance?

SANG-A PETROLATUM GAUZE USP STERILE received FDA 510(k) clearance on 1984-09-20, under 510(k) number K843035.

Who is the listed applicant for SANG-A PETROLATUM GAUZE USP STERILE?

The FDA 510(k) record lists Tech-Cons Ltd., Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANG-A PETROLATUM GAUZE USP STERILE?

The FDA product code for SANG-A PETROLATUM GAUZE USP STERILE is FRO. This falls under the Anesthesiology category.

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Other records listing Tech-Cons Ltd., Intl. 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.

K843117GREEN CROSS URINARY DRAINAGE BAGK842228AIMED FOLEY CATHETER VARIOUS SIZESK842230AIMED DISPOS. INJECTION NEEDLEK842255AIMED SCALP VEIN SET VARIOUSK842227AIMED DISPOSABLE SYRINGE, VARIOUS SIZES

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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