The following data is part of a premarket notification filed by Tlc Tech Lab Clothes, Inc. with the FDA for Tlc Surgical Drapes.
| Device ID | K951474 |
| 510k Number | K951474 |
| Device Name: | TLC SURGICAL DRAPES |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | TLC TECH LAB CLOTHES, INC. 2875 LEON ST. Muskegon, MI 49441 |
| Contact | Dawn Erickson-stevens |
| Correspondent | Dawn Erickson-stevens TLC TECH LAB CLOTHES, INC. 2875 LEON ST. Muskegon, MI 49441 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-30 |
| Decision Date | 1995-08-18 |