The following data is part of a premarket notification filed by Pasture Pharma Pte Ltd with the FDA for Pasture F550s Surgical N95 Respirator, Pasture F550cs Surgical N95 Respirator, Pasture A520s Surgical N95 Respirator, Pasture A520cs Surgical N95 Respirator, Pasture E520s Surgical N95 Respirator, Pasture E520cs Surgical N95 Respirator.
| Device ID | K141876 |
| 510k Number | K141876 |
| Device Name: | Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator |
| Classification | Respirator, Surgical |
| Applicant | PASTURE PHARMA PTE LTD 38129 SPRING CANYON DRIVE Murrieta, CA 92563 |
| Contact | Sarah Hassan |
| Correspondent | Sarah Hassan PASTURE PHARMA PTE LTD 38129 SPRING CANYON DRIVE Murrieta, CA 92563 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2015-10-28 |
| Summary: | summary |