STERILE ULTRASOUND TRANSMISSION GEL— 510(k) K894490

Name: FDA 510(k) clearance K894490
Creator: U.S. Food and Drug Administration
Published: 1989-10-05

Substantially Equivalent

Swedish Trade Council USA

FDA 510(k) clearance K894490 for STERILE ULTRASOUND TRANSMISSION GEL, Substantially Equivalent on 1989-10-05. Applicant: Swedish Trade Council USA. Device class: 2.

Clearance details

Applicant: Swedish Trade Council USA
Product code: Code JOT
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1989-07-18
Decision date: 1989-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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