The following data is part of a premarket notification filed by Louis M. Gerson Co., Inc. with the FDA for Isolair 2 Full Face Splash Guard.
| Device ID | K931288 |
| 510k Number | K931288 |
| Device Name: | ISOLAIR 2 FULL FACE SPLASH GUARD |
| Classification | Accessory, Surgical Apparel |
| Applicant | LOUIS M. GERSON CO., INC. Middleboro, MA 02346 |
| Contact | Kathleen Wesley |
| Correspondent | Kathleen Wesley LOUIS M. GERSON CO., INC. Middleboro, MA 02346 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-12 |
| Decision Date | 1994-01-21 |