PRISTINE— 510(k) K844236

Substantially Equivalent

Medical Dimensions

FDA 510(k) clearance K844236 for PRISTINE, Substantially Equivalent on 1984-11-21. Applicant: Medical Dimensions. Device class: 1.

Clearance details

Applicant
Medical Dimensions
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
Santa Monica, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.