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FDA 510(k)

DURAHESIVE WAFER WITH FLANGE

K-Number: K855018 · 1986-02-04

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1986-02-04
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DURAHESIVE WAFER WITH FLANGE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K855018. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAHESIVE WAFER WITH FLANGE?

DURAHESIVE WAFER WITH FLANGE is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K855018.

When did DURAHESIVE WAFER WITH FLANGE receive FDA 510(k) clearance?

DURAHESIVE WAFER WITH FLANGE received FDA 510(k) clearance on 1986-02-04, under 510(k) number K855018.

Who is the listed applicant for DURAHESIVE WAFER WITH FLANGE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURAHESIVE WAFER WITH FLANGE?

The FDA product code for DURAHESIVE WAFER WITH FLANGE is EXB.

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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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