The following data is part of a premarket notification filed by Lac Mac, Ltd. with the FDA for Lac-mac Limited Innerbloc O.r. Gown.
| Device ID | K030536 |
| 510k Number | K030536 |
| Device Name: | LAC-MAC LIMITED INNERBLOC O.R. GOWN |
| Classification | Gown, 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-05-06 |