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FDA 510(k)

REPLICARE (ADDITIONAL CLAIMS)

K-Number: K883849 · 1989-02-08

ApplicantUnited Medical
Decision Date1989-02-08
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

REPLICARE (ADDITIONAL CLAIMS) is the device name listed in this FDA 510(k) record. The listed applicant is United Medical. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K883849. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the REPLICARE (ADDITIONAL CLAIMS)?

REPLICARE (ADDITIONAL CLAIMS) is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is United Medical. The 510(k) number is K883849.

When did REPLICARE (ADDITIONAL CLAIMS) receive FDA 510(k) clearance?

REPLICARE (ADDITIONAL CLAIMS) received FDA 510(k) clearance on 1989-02-08, under 510(k) number K883849.

Who is the listed applicant for REPLICARE (ADDITIONAL CLAIMS)?

The FDA 510(k) record lists United Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPLICARE (ADDITIONAL CLAIMS)?

The FDA product code for REPLICARE (ADDITIONAL CLAIMS) is NAD.

Related Clinical Trials

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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Other records listing United Medical 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.

K880299REPLICAREK863389UNITED WOUND COVERING, PACKAGE OF 5K802828LIXIVITRON

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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