The following data is part of a premarket notification filed by Louis M. Gerson Co., Inc. with the FDA for Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator.
| Device ID | K050193 |
| 510k Number | K050193 |
| Device Name: | GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR |
| Classification | Respirator, Surgical |
| Applicant | LOUIS M. GERSON CO., INC. 15 SPROAT ST. Middleboro, MA 02346 |
| Contact | Robert Brunell |
| Correspondent | Robert Brunell LOUIS M. GERSON CO., INC. 15 SPROAT ST. Middleboro, MA 02346 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-27 |
| Decision Date | 2005-04-11 |