The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Skin Tech. Isotex 86l.
| Device ID | K840609 |
| 510k Number | K840609 |
| Device Name: | SKIN TECH. ISOTEX 86L |
| Classification | Tape And Bandage, Adhesive |
| Applicant | LECTEC CORP. 10205 CROSSTOWN CIRCLE Eden Prairie , MN 55344 - |
| Contact | Peter Jachimowic |
| Correspondent | Peter Jachimowic LECTEC CORP. 10205 CROSSTOWN CIRCLE Eden Prairie , MN 55344 - |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-13 |
| Decision Date | 1984-10-31 |