PNEUMATIC WIRE TENSIONER— 510(k) K934431

Name: FDA 510(k) clearance K934431
Creator: U.S. Food and Drug Administration
Published: 1994-01-27

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K934431 for PNEUMATIC WIRE TENSIONER, Substantially Equivalent on 1994-01-27. Applicant: Smith & Nephew Richards, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1993-09-13
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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