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FDA 510(k)

TEPHAFLEX SURGICAL FILM

K-Number: K072520 · 2007-11-29

ApplicantTepha, Inc.
Decision Date2007-11-29
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TEPHAFLEX SURGICAL FILM is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2007-11-29 under 510(k) number K072520. 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 TEPHAFLEX SURGICAL FILM?

TEPHAFLEX SURGICAL FILM is a medical device that received FDA 510(k) clearance on 2007-11-29. The listed applicant is Tepha, Inc.. The 510(k) number is K072520.

When did TEPHAFLEX SURGICAL FILM receive FDA 510(k) clearance?

TEPHAFLEX SURGICAL FILM received FDA 510(k) clearance on 2007-11-29, under 510(k) number K072520.

Who is the listed applicant for TEPHAFLEX SURGICAL FILM?

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

What is the FDA product code for TEPHAFLEX SURGICAL FILM?

The FDA product code for TEPHAFLEX SURGICAL FILM is FTL.

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Other records listing Tepha, Inc. as applicant

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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.

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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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