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FDA 510(k)

PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.

K-Number: K870430 · 1987-04-13

ApplicantSteridyne Laboratories, Inc.
Decision Date1987-04-13
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. 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 1987-04-13 under 510(k) number K870430. 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 for Some Indications.

Frequently Asked Questions

What is the PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.?

PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. is a medical device that received FDA 510(k) clearance on 1987-04-13. The listed applicant is Steridyne Laboratories, Inc.. The 510(k) number is K870430.

When did PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. receive FDA 510(k) clearance?

PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. received FDA 510(k) clearance on 1987-04-13, under 510(k) number K870430.

Who is the listed applicant for PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.?

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 PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.?

The FDA product code for PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. is FRO. This falls under the Anesthesiology category.

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 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.

K870431GAUZE, ABSORBENT, IODOFORM IMPREGNATED

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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

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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