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FDA 510(k)

AMOENA AFFINITY MODEL #802

K-Number: K915382 · 1992-01-14

ApplicantColoplast Corp.
Decision Date1992-01-14
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMOENA AFFINITY 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 1992-01-14 under 510(k) number K915382. 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 AMOENA AFFINITY MODEL #802?

AMOENA AFFINITY MODEL #802 is a medical device that received FDA 510(k) clearance on 1992-01-14. The listed applicant is Coloplast Corp.. The 510(k) number is K915382.

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

AMOENA AFFINITY MODEL #802 received FDA 510(k) clearance on 1992-01-14, under 510(k) number K915382.

Who is the listed applicant for AMOENA AFFINITY 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 AMOENA AFFINITY MODEL #802?

The FDA product code for AMOENA AFFINITY 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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