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FDA 510(k)

DUODERM* CONTROL GEL FORMULA BORDER DRESSING

K-Number: K901155 · 1990-04-16

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1990-04-16
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUODERM* CONTROL GEL FORMULA BORDER DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K901155. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUODERM* CONTROL GEL FORMULA BORDER DRESSING?

DUODERM* CONTROL GEL FORMULA BORDER DRESSING is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K901155.

When did DUODERM* CONTROL GEL FORMULA BORDER DRESSING receive FDA 510(k) clearance?

DUODERM* CONTROL GEL FORMULA BORDER DRESSING received FDA 510(k) clearance on 1990-04-16, under 510(k) number K901155.

Who is the listed applicant for DUODERM* CONTROL GEL FORMULA BORDER DRESSING?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUODERM* CONTROL GEL FORMULA BORDER DRESSING?

The FDA product code for DUODERM* CONTROL GEL FORMULA BORDER DRESSING is KMF.

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: KMF)

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

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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