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FDA 510(k)

HOLLISTER STOMA POUCH SKIN BARRIER

K-Number: K791526 · 1979-10-26

ApplicantHollister, Inc.
Decision Date1979-10-26
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER STOMA POUCH SKIN BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K791526. 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 HOLLISTER STOMA POUCH SKIN BARRIER?

HOLLISTER STOMA POUCH SKIN BARRIER is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is Hollister, Inc.. The 510(k) number is K791526.

When did HOLLISTER STOMA POUCH SKIN BARRIER receive FDA 510(k) clearance?

HOLLISTER STOMA POUCH SKIN BARRIER received FDA 510(k) clearance on 1979-10-26, under 510(k) number K791526.

Who is the listed applicant for HOLLISTER STOMA POUCH SKIN BARRIER?

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 HOLLISTER STOMA POUCH SKIN BARRIER?

The FDA product code for HOLLISTER STOMA POUCH SKIN BARRIER 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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