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FDA 510(k)

MARLEN ULTRA ILEOSTOMY POUCH-5000

K-Number: K880327 · 1988-02-19

ApplicantMarlen Mfg. & Development Co.
Decision Date1988-02-19
Product CodeEZQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MARLEN ULTRA ILEOSTOMY POUCH-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Marlen Mfg. & Development Co.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K880327. The device is classified under product code EZQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARLEN ULTRA ILEOSTOMY POUCH-5000?

MARLEN ULTRA ILEOSTOMY POUCH-5000 is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Marlen Mfg. & Development Co.. The 510(k) number is K880327.

When did MARLEN ULTRA ILEOSTOMY POUCH-5000 receive FDA 510(k) clearance?

MARLEN ULTRA ILEOSTOMY POUCH-5000 received FDA 510(k) clearance on 1988-02-19, under 510(k) number K880327.

Who is the listed applicant for MARLEN ULTRA ILEOSTOMY POUCH-5000?

The FDA 510(k) record lists Marlen Mfg. & Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARLEN ULTRA ILEOSTOMY POUCH-5000?

The FDA product code for MARLEN ULTRA ILEOSTOMY POUCH-5000 is EZQ.

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Related Devices (Code: EZQ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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