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FDA 510(k)

DURADERM BUTTERFLY

K-Number: K881343 · 1988-05-04

ApplicantSentry Medical Products, Inc.
Decision Date1988-05-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURADERM BUTTERFLY is the device name listed in this FDA 510(k) record. The listed applicant is Sentry Medical Products, Inc.. It received FDA 510(k) clearance on 1988-05-04 under 510(k) number K881343. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURADERM BUTTERFLY?

DURADERM BUTTERFLY is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is Sentry Medical Products, Inc.. The 510(k) number is K881343.

When did DURADERM BUTTERFLY receive FDA 510(k) clearance?

DURADERM BUTTERFLY received FDA 510(k) clearance on 1988-05-04, under 510(k) number K881343.

Who is the listed applicant for DURADERM BUTTERFLY?

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

What is the FDA product code for DURADERM BUTTERFLY?

The FDA product code for DURADERM BUTTERFLY is GXY.

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Other records listing Sentry Medical Products, Inc. as applicant

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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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