ECHO-COAT ULTRASOUND NEEDLES— 510(k) K983647

Substantially Equivalent

Sts Biopolymers

FDA 510(k) clearance K983647 for ECHO-COAT ULTRASOUND NEEDLES, Substantially Equivalent on 1999-01-20. Applicant: Sts Biopolymers. Device class: 1.

Clearance details

Applicant: Sts Biopolymers
Product code: Code MJG
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1998-10-16
Decision date: 1999-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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