The following data is part of a premarket notification filed by Louis M. Gerson Co., Inc. with the FDA for Respirator N95 Particulate Respirator, Model 1730.
| Device ID | K061375 |
| 510k Number | K061375 |
| Device Name: | RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 |
| 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 | 2006-05-17 |
| Decision Date | 2006-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817517020199 | K061375 | 000 |
| 00817517020182 | K061375 | 000 |
| 50096295137380 | K061375 | 000 |
| D79011548013 | K061375 | 000 |
| 50732224004698 | K061375 | 000 |
| 00044585917308 | K061375 | 000 |
| 50732224004919 | K061375 | 000 |