MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA— 510(k) K861046

Name: FDA 510(k) clearance K861046
Creator: U.S. Food and Drug Administration
Published: 1986-05-02

Substantially Equivalent

Sharplan Industries, Inc.

FDA 510(k) clearance K861046 for MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA, Substantially Equivalent on 1986-05-02. Applicant: Sharplan Industries, Inc.. Device class: 2.

Clearance details

Applicant: Sharplan Industries, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1986-03-18
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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