The following data is part of a premarket notification filed by Pasture Pharma Pte Ltd with the FDA for Pasture, Models: F550, A520.
| Device ID | K083176 |
| 510k Number | K083176 |
| Device Name: | PASTURE, MODELS: F550, A520 |
| Classification | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Applicant | PASTURE PHARMA PTE LTD 29266 VIA FRONTERA Murrieta, CA 92563 |
| Contact | Sarah Hassan |
| Correspondent | Sarah Hassan PASTURE PHARMA PTE LTD 29266 VIA FRONTERA Murrieta, CA 92563 |
| Product Code | NZJ |
| CFR Regulation Number | 880.6260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B624F550G30 | K083176 | 000 |
| B624F550G200 | K083176 | 000 |
| B624A520G200 | K083176 | 000 |