The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Dress, Surgical Adhesive.
Device ID | K833590 |
510k Number | K833590 |
Device Name: | DRESS, SURGICAL ADHESIVE |
Classification | Tape And Bandage, Adhesive |
Applicant | LECTEC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-12 |
Decision Date | 1984-01-27 |