510(k) K771409
K771409 is an FDA 510(k) premarket notification submitted by Precept, Inc. for the device "DISP. SURGICAL FACE MASK". The FDA issued a decision of Substantially Equivalent on October 27, 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
- October 27, 1977
- Date Received
- August 1, 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