The following data is part of a premarket notification filed by Lee Tec Corp. with the FDA for Skin Tech. Surgi-strips.
Device ID | K833258 |
510k Number | K833258 |
Device Name: | SKIN TECH. SURGI-STRIPS |
Classification | Strip, Adhesive, Closure, Skin |
Applicant | LEE TEC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-20 |
Decision Date | 1984-01-25 |