INTRASITE— 510(k) K942748

Name: FDA 510(k) clearance K942748
Creator: U.S. Food and Drug Administration
Published: 1994-06-29

Substantially Equivalent for Some Indications

Smith & Nephew United, Inc.

FDA 510(k) clearance K942748 for INTRASITE, Substantially Equivalent for Some Indications on 1994-06-29. Applicant: Smith & Nephew United, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1994-06-10
Decision date: 1994-06-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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