TECHNOMED PULSOLITH LASER SYSTEM— 510(k) K895178

Name: FDA 510(k) clearance K895178
Creator: U.S. Food and Drug Administration
Published: 1989-10-06

Substantially Equivalent

Teknomed, Inc.

FDA 510(k) clearance K895178 for TECHNOMED PULSOLITH LASER SYSTEM, Substantially Equivalent on 1989-10-06. Applicant: Teknomed, Inc.. Device class: 2.

Clearance details

Applicant: Teknomed, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-10
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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