PNEUMATIC POWERED BUR— 510(k) K780139

Substantially Equivalent

North Palm Beach Orthodepic Assoc.

FDA 510(k) clearance K780139 for PNEUMATIC POWERED BUR, Substantially Equivalent on 1978-02-01. Applicant: North Palm Beach Orthodepic Assoc.. Device class: 1.

Clearance details

Applicant
North Palm Beach Orthodepic Assoc.
Product code
Code HSZ
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HSZ

view all

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