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FDA 510(k)

FORTAGEN ORAL MEMBRANE

K-Number: K071555 · 2007-08-30

ApplicantOrganogenesis, Inc.
Decision Date2007-08-30
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FORTAGEN ORAL MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2007-08-30 under 510(k) number K071555. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTAGEN ORAL MEMBRANE?

FORTAGEN ORAL MEMBRANE is a medical device that received FDA 510(k) clearance on 2007-08-30. The listed applicant is Organogenesis, Inc.. The 510(k) number is K071555.

When did FORTAGEN ORAL MEMBRANE receive FDA 510(k) clearance?

FORTAGEN ORAL MEMBRANE received FDA 510(k) clearance on 2007-08-30, under 510(k) number K071555.

Who is the listed applicant for FORTAGEN ORAL MEMBRANE?

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

What is the FDA product code for FORTAGEN ORAL MEMBRANE?

The FDA product code for FORTAGEN ORAL MEMBRANE is NPL.

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Other records listing Organogenesis, Inc. as applicant

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Related Devices (Code: NPL)

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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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