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FDA 510(k)

FLARED PATCH

K-Number: K941299 · 1994-08-23

Decision Date1994-08-23
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLARED PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Flared Patch, Inc.. It received FDA 510(k) clearance on 1994-08-23 under 510(k) number K941299. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLARED PATCH?

FLARED PATCH is a medical device that received FDA 510(k) clearance on 1994-08-23. The listed applicant is Flared Patch, Inc.. The 510(k) number is K941299.

When did FLARED PATCH receive FDA 510(k) clearance?

FLARED PATCH received FDA 510(k) clearance on 1994-08-23, under 510(k) number K941299.

Who is the listed applicant for FLARED PATCH?

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

What is the FDA product code for FLARED PATCH?

The FDA product code for FLARED PATCH is FTL.

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.

Related Devices (Code: FTL)

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.

Official Source

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