INTRASITE GEL (LABELING REVISION)— 510(k) K904411

Name: FDA 510(k) clearance K904411
Creator: U.S. Food and Drug Administration
Published: 1990-11-26

Substantially Equivalent for Some Indications

Smith & Nephew United, Inc.

FDA 510(k) clearance K904411 for INTRASITE GEL (LABELING REVISION), Substantially Equivalent for Some Indications on 1990-11-26. Applicant: Smith & Nephew United, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1990-09-26
Decision date: 1990-11-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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