510(k) K911334
K911334 is an FDA 510(k) premarket notification submitted by Thai Hospital Products Co., Ltd. for the device "MASK, SURGICAL APPAREL". The FDA issued a decision of Substantially Equivalent on Aug 29, 1991. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 1991
- Date Received
- Mar 26, 1991
- 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
- 510(k)