The following data is part of a premarket notification filed by Lac Mac, Ltd. with the FDA for Innerbloc Lr Surgical Gowns Based On Gore Lr Fabric (reusable 100x).
| Device ID | K032631 |
| 510k Number | K032631 |
| Device Name: | INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) |
| Classification | Gown, Surgical |
| Applicant | LAC MAC, LTD. 10907 WAREHAM COURT Austin, TX 78739 |
| Contact | Jefrrey O Stull |
| Correspondent | Jefrrey O Stull LAC MAC, LTD. 10907 WAREHAM COURT Austin, TX 78739 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-26 |
| Decision Date | 2004-02-05 |