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FDA 510(k)

TWO PIECE OSTOMY SYSTEM

K-Number: K813269 · 1981-12-03

ApplicantHollister, Inc.
Decision Date1981-12-03
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TWO PIECE OSTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1981-12-03 under 510(k) number K813269. 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 TWO PIECE OSTOMY SYSTEM?

TWO PIECE OSTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is Hollister, Inc.. The 510(k) number is K813269.

When did TWO PIECE OSTOMY SYSTEM receive FDA 510(k) clearance?

TWO PIECE OSTOMY SYSTEM received FDA 510(k) clearance on 1981-12-03, under 510(k) number K813269.

Who is the listed applicant for TWO PIECE OSTOMY SYSTEM?

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

What is the FDA product code for TWO PIECE OSTOMY SYSTEM?

The FDA product code for TWO PIECE OSTOMY SYSTEM 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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