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FDA 510(k)

ALGINATE FIBER

K-Number: K905040 · 1991-08-21

ApplicantShepherd Medical Corp.
Decision Date1991-08-21
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

ALGINATE FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Shepherd Medical Corp.. It received FDA 510(k) clearance on 1991-08-21 under 510(k) number K905040. 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 ALGINATE FIBER?

ALGINATE FIBER is a medical device that received FDA 510(k) clearance on 1991-08-21. The listed applicant is Shepherd Medical Corp.. The 510(k) number is K905040.

When did ALGINATE FIBER receive FDA 510(k) clearance?

ALGINATE FIBER received FDA 510(k) clearance on 1991-08-21, under 510(k) number K905040.

Who is the listed applicant for ALGINATE FIBER?

The FDA 510(k) record lists Shepherd Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGINATE FIBER?

The FDA product code for ALGINATE FIBER 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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Related Devices (Code: FRO)

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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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