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FDA 510(k)

ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)

K-Number: K072560 · 2008-06-17

ApplicantTeikoku Pharma USA, Inc.
Decision Date2008-06-17
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) is the device name listed in this FDA 510(k) record. The listed applicant is Teikoku Pharma USA, Inc.. It received FDA 510(k) clearance on 2008-06-17 under 510(k) number K072560. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)?

ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) is a medical device that received FDA 510(k) clearance on 2008-06-17. The listed applicant is Teikoku Pharma USA, Inc.. The 510(k) number is K072560.

When did ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) receive FDA 510(k) clearance?

ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) received FDA 510(k) clearance on 2008-06-17, under 510(k) number K072560.

Who is the listed applicant for ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)?

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

What is the FDA product code for ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)?

The FDA product code for ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) is NAD.

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Related Devices (Code: NAD)

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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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