PARADERM(TM) SURGEON'S GLOVE ACCESSORY— 510(k) K904903

Name: FDA 510(k) clearance K904903
Creator: U.S. Food and Drug Administration
Published: 1991-01-08

Substantially Equivalent

Lovell-Schenck, Inc.

FDA 510(k) clearance K904903 for PARADERM(TM) SURGEON'S GLOVE ACCESSORY, Substantially Equivalent on 1991-01-08. Applicant: Lovell-Schenck, Inc.. Device class: 1.

Clearance details

Applicant: Lovell-Schenck, Inc.
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1990-10-29
Decision date: 1991-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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