The following data is part of a premarket notification filed by Louis M. Gerson Co., Inc. with the FDA for Isolair Apr Type N95.
| Device ID | K960778 |
| 510k Number | K960778 |
| Device Name: | ISOLAIR APR TYPE N95 |
| Classification | Respirator, Surgical |
| Applicant | LOUIS M. GERSON CO., INC. 15 SPROAT ST. Middleboro, MA 02346 |
| Contact | Joseph Z Zdrok |
| Correspondent | Joseph Z Zdrok 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 | 1996-02-26 |
| Decision Date | 1996-05-09 |
| Summary: | summary |