The following data is part of a premarket notification filed by Pasture Pharma Pte Ltd with the FDA for Pasture 60s Surgical Mask.
| Device ID | K141875 |
| 510k Number | K141875 |
| Device Name: | Pasture 60S Surgical Mask |
| Classification | Mask, 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 | FXX |
| 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 | 2015-05-05 |
| Summary: | summary |