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FDA 510(k)

IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX

K-Number: K071470 · 2007-08-31

ApplicantImplantech Associates, Inc.
Decision Date2007-08-31
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K071470. 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 IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX?

IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K071470.

When did IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX receive FDA 510(k) clearance?

IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX received FDA 510(k) clearance on 2007-08-31, under 510(k) number K071470.

Who is the listed applicant for IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX?

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

What is the FDA product code for IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX?

The FDA product code for IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX is FTL.

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Other records listing Implantech Associates, 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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