510(k) K141875
K141875 is an FDA 510(k) premarket notification submitted by Pasture Pharma Pte, Ltd. for the device "Pasture 60S Surgical Mask". The FDA issued a decision of Substantially Equivalent on May 5, 2015. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Pasture Pharma Pte, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2015
- Date Received
- July 11, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type