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FDA 510(k)

DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING

K-Number: K891696 · 1989-05-04

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1989-05-04
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID 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 1989-05-04 under 510(k) number K891696. 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 DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING?

DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING is a medical device that received FDA 510(k) clearance on 1989-05-04. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K891696.

When did DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING receive FDA 510(k) clearance?

DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING received FDA 510(k) clearance on 1989-05-04, under 510(k) number K891696.

Who is the listed applicant for DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID 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* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING?

The FDA product code for DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING is NAD.

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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: 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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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