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FDA 510(k)

AREOLA/NIPPLE DRESSING

K-Number: K882558 · 1989-05-24

ApplicantCooper Surgical/Aesthete
Decision Date1989-05-24
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AREOLA/NIPPLE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Surgical/Aesthete. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K882558. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AREOLA/NIPPLE DRESSING?

AREOLA/NIPPLE DRESSING is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Cooper Surgical/Aesthete. The 510(k) number is K882558.

When did AREOLA/NIPPLE DRESSING receive FDA 510(k) clearance?

AREOLA/NIPPLE DRESSING received FDA 510(k) clearance on 1989-05-24, under 510(k) number K882558.

Who is the listed applicant for AREOLA/NIPPLE DRESSING?

The FDA 510(k) record lists Cooper Surgical/Aesthete as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AREOLA/NIPPLE DRESSING?

The FDA product code for AREOLA/NIPPLE DRESSING is NAD.

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Related Devices (Code: NAD)

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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