510(k) K770463
K770463 is an FDA 510(k) premarket notification submitted by Precept, Inc. for the device "MASK, SURGICAL, FACE, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on March 23, 1977. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Precept, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1977
- Date Received
- March 9, 1977
- 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