The following data is part of a premarket notification filed by Lac Mac, Ltd. with the FDA for Lac-mac Innerbloc Lr Surgical Gowns.
| Device ID | K092344 |
| 510k Number | K092344 |
| Device Name: | LAC-MAC INNERBLOC LR SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | LAC MAC, LTD. 7809 ADELAIDE DR. Austin, TX 78739 |
| Contact | Jeffrey O Stull |
| Correspondent | Jeffrey O Stull LAC MAC, LTD. 7809 ADELAIDE DR. Austin, TX 78739 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-12-17 |