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FDA 510(k)

PRIMAPORE I.V.

K-Number: K893900 · 1989-08-03

ApplicantSmith & Nephew United, Inc.
Decision Date1989-08-03
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

PRIMAPORE I.V. is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K893900. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PRIMAPORE I.V.?

PRIMAPORE I.V. is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K893900.

When did PRIMAPORE I.V. receive FDA 510(k) clearance?

PRIMAPORE I.V. received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893900.

Who is the listed applicant for PRIMAPORE I.V.?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMAPORE I.V.?

The FDA product code for PRIMAPORE I.V. is KGX.

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Other records listing Smith & Nephew United, Inc. 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.

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGK961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSING

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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