The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Isopore Tape.
Device ID | K922959 |
510k Number | K922959 |
Device Name: | ISOPORE TAPE |
Classification | Tape And Bandage, Adhesive |
Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Contact | Chad Miller |
Correspondent | Chad Miller LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-18 |
Decision Date | 1992-09-11 |