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FDA 510(k)

BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES

K-Number: K870184 · 1987-02-06

ApplicantFraass Survival Systems, Inc.
Decision Date1987-02-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES is the device name listed in this FDA 510(k) record. The listed applicant is Fraass Survival Systems, Inc.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K870184. 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 BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES?

BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Fraass Survival Systems, Inc.. The 510(k) number is K870184.

When did BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES receive FDA 510(k) clearance?

BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES received FDA 510(k) clearance on 1987-02-06, under 510(k) number K870184.

Who is the listed applicant for BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES?

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

What is the FDA product code for BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES?

The FDA product code for BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES is FRO. This falls under the Anesthesiology category.

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Other records listing Fraass Survival Systems, Inc. as applicant

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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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