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FDA 510(k)

HOLLISTER UROSTOMY POUCH

K-Number: K791534 · 1979-10-09

ApplicantHollister, Inc.
Decision Date1979-10-09
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER UROSTOMY POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1979-10-09 under 510(k) number K791534. 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 UROSTOMY POUCH?

HOLLISTER UROSTOMY POUCH is a medical device that received FDA 510(k) clearance on 1979-10-09. The listed applicant is Hollister, Inc.. The 510(k) number is K791534.

When did HOLLISTER UROSTOMY POUCH receive FDA 510(k) clearance?

HOLLISTER UROSTOMY POUCH received FDA 510(k) clearance on 1979-10-09, under 510(k) number K791534.

Who is the listed applicant for HOLLISTER UROSTOMY POUCH?

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 UROSTOMY POUCH?

The FDA product code for HOLLISTER UROSTOMY POUCH 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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