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FDA 510(k)

RETRO-TECH DRESSING

K-Number: K060832 · 2007-03-13

ApplicantRetro-Tech, LLC
Decision Date2007-03-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

RETRO-TECH DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Retro-Tech, LLC. It received FDA 510(k) clearance on 2007-03-13 under 510(k) number K060832. 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 RETRO-TECH DRESSING?

RETRO-TECH DRESSING is a medical device that received FDA 510(k) clearance on 2007-03-13. The listed applicant is Retro-Tech, LLC. The 510(k) number is K060832.

When did RETRO-TECH DRESSING receive FDA 510(k) clearance?

RETRO-TECH DRESSING received FDA 510(k) clearance on 2007-03-13, under 510(k) number K060832.

Who is the listed applicant for RETRO-TECH DRESSING?

The FDA 510(k) record lists Retro-Tech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETRO-TECH DRESSING?

The FDA product code for RETRO-TECH DRESSING is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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