K832149Substantially Equivalent

Pdm Siloxane Prosthetic Obturator

Name: K832149 Pdm Siloxane Prosthetic Obturator
Creator: Delaware Prosthetics, Inc.
Published: 1983-11-28
License: https://open.fda.gov/license/

Delaware Prosthetics, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K832149 is the FDA 510(k) clearance record for PDM SILOXANE PROSTHETIC OBTURATOR, cleared for Delaware Prosthetics, Inc. on 1983-11-28. FDA records list 5 510(k) clearances for Delaware Prosthetics, Inc., from 1983-11-28 to 1983-12-19. As of 2026-09-10, FDA records show no recalls naming K832149.

Clearance record

Decision date: 1983-11-28
Received: 1983-07-05 (146 days to decision)
Review panel: Unknown
Applicant: Delaware Prosthetics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No