SIME SURGICAL POWDERFREE— 510(k) K954025

Substantially Equivalent

Sime Health, Ltd.

FDA 510(k) clearance K954025 for SIME SURGICAL POWDERFREE, Substantially Equivalent on 1995-11-15. Applicant: Sime Health, Ltd.. Device class: 1.

Clearance details

Applicant
Sime Health, Ltd.
Product code
Code KGO
Device class
Class 1
Regulation
21 CFR 878.4460
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck,, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KGO

view all

More clearances from Sime Health, Ltd.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.