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FDA 510(k)

GAUZE, ABSORBENT, IODOFORM IMPREGNATED

K-Number: K870431 · 1987-02-26

ApplicantSteridyne Laboratories, Inc.
Decision Date1987-02-26
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

GAUZE, ABSORBENT, IODOFORM IMPREGNATED is the device name listed in this FDA 510(k) record. The listed applicant is Steridyne Laboratories, Inc.. It received FDA 510(k) clearance on 1987-02-26 under 510(k) number K870431. 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 GAUZE, ABSORBENT, IODOFORM IMPREGNATED?

GAUZE, ABSORBENT, IODOFORM IMPREGNATED is a medical device that received FDA 510(k) clearance on 1987-02-26. The listed applicant is Steridyne Laboratories, Inc.. The 510(k) number is K870431.

When did GAUZE, ABSORBENT, IODOFORM IMPREGNATED receive FDA 510(k) clearance?

GAUZE, ABSORBENT, IODOFORM IMPREGNATED received FDA 510(k) clearance on 1987-02-26, under 510(k) number K870431.

Who is the listed applicant for GAUZE, ABSORBENT, IODOFORM IMPREGNATED?

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

What is the FDA product code for GAUZE, ABSORBENT, IODOFORM IMPREGNATED?

The FDA product code for GAUZE, ABSORBENT, IODOFORM IMPREGNATED is FRO. This falls under the Anesthesiology category.

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Other records listing Steridyne Laboratories, 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.

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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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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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