The following data is part of a premarket notification filed by Lac Mac, Ltd. with the FDA for Lac-mac Limited Innerbloc Various O.r. Drape Based On The Repel, Plus And Gore Surgical Barrier Fabric Materials.
| Device ID | K031362 |
| 510k Number | K031362 |
| Device Name: | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS |
| Classification | Drape, Surgical |
| Applicant | LAC MAC, LTD. 10907 WAREHAM COURT Austin, TX 78739 |
| Contact | Jeffrey O Stull |
| Correspondent | Jeffrey O Stull LAC MAC, LTD. 10907 WAREHAM COURT Austin, TX 78739 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-05-30 |