FDA 510(k)

INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)

K-Number: K901879 · 1990-06-22

Decision Date1990-06-22

Product CodeKGX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) 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 1990-06-22 under 510(k) number K901879. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)?

INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K901879.

When did INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) receive FDA 510(k) clearance?

INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) received FDA 510(k) clearance on 1990-06-22, under 510(k) number K901879.

Who is the listed applicant for INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)?

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 INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)?

The FDA product code for INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) is KGX.

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Other records listing Smith & Nephew United, Inc. as applicant

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING K961775PROFORE FOUR-LAYER BANDAGE SYSTEM KIT K945330ALLEVYN ADHESIVE K943619CAVI-CARE CONFORMING FOAM DRESSING K942748INTRASITE K935705ALLEVYN ISLAND WOUND DRESSING

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Related Devices (Code: KGX)

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.