The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Isopore(tm) Tape, Modification.
| Device ID | K925384 |
| 510k Number | K925384 |
| Device Name: | ISOPORE(TM) TAPE, MODIFICATION |
| 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 | 1992-10-26 |
| Decision Date | 1993-04-21 |