K833686Substantially Equivalent

Filtech Technetium-99Mm Radiopharmaceu

Name: K833686 Filtech Technetium-99Mm Radiopharmaceu
Creator: Summa Medical Corp.
Published: 1984-02-28
License: https://open.fda.gov/license/

Summa Medical Corp., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K833686 is the FDA 510(k) clearance record for FILTECH TECHNETIUM-99MM RADIOPHARMACEU, cleared for Summa Medical Corp. on 1984-02-28. FDA records list one 510(k) clearance for Summa Medical Corp. As of 2026-09-10, FDA records show no recalls naming K833686.

Clearance record

Decision date: 1984-02-28
Received: 1983-10-31 (120 days to decision)
Review panel: Unknown
Applicant: Summa Medical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No