K772031Substantially Equivalent

Gemsaec Appli. for Ultrazyme Plus Y-Gt

Name: K772031 Gemsaec Appli. for Ultrazyme Plus Y-Gt
Creator: Harleco
Published: 1977-11-14
License: https://open.fda.gov/license/

Harleco, Mchenry IL / Traditional, Substantially Equivalent

FDA source

K772031 is the FDA 510(k) clearance record for GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT, cleared for Harleco on 1977-11-14. FDA records list 116 510(k) clearances for Harleco, from 1976-07-20 to 1982-02-12. As of 2026-09-10, FDA records show no recalls naming K772031.

Clearance record

Decision date: 1977-11-14
Received: 1977-10-27 (18 days to decision)
Review panel: Unknown
Applicant: Harleco 803 N. Front St. Suite 3, Mchenry IL
Third party review: No