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FDA 510(k)

HOLLISTER DRAINAGE POUCH

K-Number: K801504 · 1980-08-12

ApplicantHollister, Inc.
Decision Date1980-08-12
Product CodeFON
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER DRAINAGE 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 1980-08-12 under 510(k) number K801504. The device is classified under product code FON. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLLISTER DRAINAGE POUCH?

HOLLISTER DRAINAGE POUCH is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is Hollister, Inc.. The 510(k) number is K801504.

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

HOLLISTER DRAINAGE POUCH received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801504.

Who is the listed applicant for HOLLISTER DRAINAGE 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 DRAINAGE POUCH?

The FDA product code for HOLLISTER DRAINAGE POUCH is FON.

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Related Devices (Code: FON)

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.

K772366BAG, DRAINAGEW/ADHESIVE; PROSTHESISAtlantic SurgicalK770826POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITEHowmedica Corp.

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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