TECHNOMED PULSOLITH 4000 LASER SYSTEM— 510(k) K925395

Name: FDA 510(k) clearance K925395
Creator: U.S. Food and Drug Administration
Published: 1993-05-21

Substantially Equivalent

Teknomed, Inc.

FDA 510(k) clearance K925395 for TECHNOMED PULSOLITH 4000 LASER SYSTEM, Substantially Equivalent on 1993-05-21. Applicant: Teknomed, Inc.. Device class: 2.

Clearance details

Applicant: Teknomed, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1992-10-26
Decision date: 1993-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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