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FDA 510(k)

SUOENA AFFINITY (TM) MODEL #802

K-Number: K921535 · 1992-05-11

ApplicantColoplast Corp.
Decision Date1992-05-11
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUOENA AFFINITY (TM) MODEL #802 is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K921535. The device is classified under product code KCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUOENA AFFINITY (TM) MODEL #802?

SUOENA AFFINITY (TM) MODEL #802 is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Coloplast Corp.. The 510(k) number is K921535.

When did SUOENA AFFINITY (TM) MODEL #802 receive FDA 510(k) clearance?

SUOENA AFFINITY (TM) MODEL #802 received FDA 510(k) clearance on 1992-05-11, under 510(k) number K921535.

Who is the listed applicant for SUOENA AFFINITY (TM) MODEL #802?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUOENA AFFINITY (TM) MODEL #802?

The FDA product code for SUOENA AFFINITY (TM) MODEL #802 is KCZ.

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Related Devices (Code: KCZ)

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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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