510(k) K962443
K962443 is an FDA 510(k) premarket notification submitted by Survivair, Inc. for the device "N95 FILTERING FACEPIECE". The FDA issued a decision of Substantially Equivalent on January 3, 1997. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Survivair, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1997
- Date Received
- June 24, 1996
- 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