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FDA 510(k)

OSTOMY APPLIANCE W/DEODORIZING FILTER

K-Number: K781373 · 1978-09-20

ApplicantHollister, Inc.
Decision Date1978-09-20
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OSTOMY APPLIANCE W/DEODORIZING FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1978-09-20 under 510(k) number K781373. 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 OSTOMY APPLIANCE W/DEODORIZING FILTER?

OSTOMY APPLIANCE W/DEODORIZING FILTER is a medical device that received FDA 510(k) clearance on 1978-09-20. The listed applicant is Hollister, Inc.. The 510(k) number is K781373.

When did OSTOMY APPLIANCE W/DEODORIZING FILTER receive FDA 510(k) clearance?

OSTOMY APPLIANCE W/DEODORIZING FILTER received FDA 510(k) clearance on 1978-09-20, under 510(k) number K781373.

Who is the listed applicant for OSTOMY APPLIANCE W/DEODORIZING FILTER?

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 OSTOMY APPLIANCE W/DEODORIZING FILTER?

The FDA product code for OSTOMY APPLIANCE W/DEODORIZING FILTER is EXB.

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Related Devices (Code: EXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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