The following data is part of a premarket notification filed by Sri/surgical Express with the FDA for Sri Plr Gown.
Device ID | K080707 |
510k Number | K080707 |
Device Name: | SRI PLR GOWN |
Classification | Gown, Surgical |
Applicant | SRI/SURGICAL EXPRESS P.O. BOX 92493 Austin, TX 78709 |
Contact | Jeffrey O Stull |
Correspondent | Jeffrey O Stull SRI/SURGICAL EXPRESS P.O. BOX 92493 Austin, TX 78709 |
Product Code | FYA |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-12 |
Decision Date | 2008-11-13 |