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 |