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FDA 510(k)

BOO-BOO STRIP

K-Number: K830640 · 1983-05-04

ApplicantColossus Corp.
Decision Date1983-05-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BOO-BOO STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Colossus Corp.. It received FDA 510(k) clearance on 1983-05-04 under 510(k) number K830640. 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 BOO-BOO STRIP?

BOO-BOO STRIP is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Colossus Corp.. The 510(k) number is K830640.

When did BOO-BOO STRIP receive FDA 510(k) clearance?

BOO-BOO STRIP received FDA 510(k) clearance on 1983-05-04, under 510(k) number K830640.

Who is the listed applicant for BOO-BOO STRIP?

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

What is the FDA product code for BOO-BOO STRIP?

The FDA product code for BOO-BOO STRIP is FRO. This falls under the Anesthesiology category.

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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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