K770815Substantially Equivalent

Ultrazyme Plus Gt

Name: K770815 Ultrazyme Plus Gt
Creator: Harleco
Published: 1977-07-11
License: https://open.fda.gov/license/

Harleco, Mchenry IL / Traditional, Substantially Equivalent

FDA source

K770815 is the FDA 510(k) clearance record for ULTRAZYME PLUS GT, cleared for Harleco on 1977-07-11. 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 K770815.

Clearance record

Decision date: 1977-07-11
Received: 1977-05-04 (68 days to decision)
Review panel: Unknown
Applicant: Harleco 803 N. Front St. Suite 3, Mchenry IL
Third party review: No