K863194Substantially Equivalent

Tenderm Tape

Name: K863194 Tenderm Tape
Creator: Lectec Corp.
Published: 1986-09-30
License: https://open.fda.gov/license/

Lectec Corp., Minnetonka MN / Traditional, Substantially Equivalent

FDA source

K863194 is the FDA 510(k) clearance record for TENDERM TAPE, cleared for Lectec Corp. on 1986-09-30. FDA records list 27 510(k) clearances for Lectec Corp., from 1977-09-20 to 1996-03-07. As of 2026-09-10, FDA records show no recalls naming K863194.

Clearance record

Decision date: 1986-09-30
Received: 1986-08-19 (42 days to decision)
Review panel: Unknown
Applicant: Lectec Corp. 10701 Red Cir. Dr., Minnetonka MN
Third party review: No