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 |