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FDA 510(k)

STOMA BAG W/SKIN BARRIER SEAL RING

K-Number: K770439 · 1977-04-15

ApplicantHollister, Inc.
Decision Date1977-04-15
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STOMA BAG W/SKIN BARRIER SEAL RING is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1977-04-15 under 510(k) number K770439. 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 STOMA BAG W/SKIN BARRIER SEAL RING?

STOMA BAG W/SKIN BARRIER SEAL RING is a medical device that received FDA 510(k) clearance on 1977-04-15. The listed applicant is Hollister, Inc.. The 510(k) number is K770439.

When did STOMA BAG W/SKIN BARRIER SEAL RING receive FDA 510(k) clearance?

STOMA BAG W/SKIN BARRIER SEAL RING received FDA 510(k) clearance on 1977-04-15, under 510(k) number K770439.

Who is the listed applicant for STOMA BAG W/SKIN BARRIER SEAL RING?

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 STOMA BAG W/SKIN BARRIER SEAL RING?

The FDA product code for STOMA BAG W/SKIN BARRIER SEAL RING 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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