510(k) K083176
K083176 is an FDA 510(k) premarket notification submitted by Pasture Pharma Pte, Ltd. for the device "PASTURE, MODELS: F550, A520". The FDA issued a decision of Substantially Equivalent on January 23, 2009. The device falls under product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies), a Class II device regulated under 21 CFR 880.6260. Pasture Pharma Pte, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2009
- Date Received
- October 28, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- Device Class
- Class II
- Regulation Number
- 880.6260
- Review Panel
- HO
- Submission Type
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.