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FDA 510(k)

NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT

K-Number: K904316 · 1990-10-11

ApplicantColoplast Corp.
Decision Date1990-10-11
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1990-10-11 under 510(k) number K904316. 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 NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT?

NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT is a medical device that received FDA 510(k) clearance on 1990-10-11. The listed applicant is Coloplast Corp.. The 510(k) number is K904316.

When did NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT receive FDA 510(k) clearance?

NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT received FDA 510(k) clearance on 1990-10-11, under 510(k) number K904316.

Who is the listed applicant for NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT?

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 NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT?

The FDA product code for NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT is KCZ.

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Other records listing Coloplast Corp. as applicant

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Related Devices (Code: KCZ)

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.

K990458STRAUMANN EXTRAORAL IMPLANT SYSTEMStraumann USAK951324MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESISMaxol Limited L.C.K933465COSMETGreat Bay Medical Products, Inc.K932978CALSSIQUE OR MYSTIQUEDekumed, Kunststofftechnik Degler GmbHK932899CLASSIQUEHemispheres Marketing Co. , Ltd.K933668ALMOST U, INC. BREAST PROSTHESISAlmost U., Inc.

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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