510(k) K922716
K922716 is an FDA 510(k) premarket notification submitted by Splash Shield, Inc. for the device "SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509". The FDA issued a decision of Substantially Equivalent on Oct 23, 1992. 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
- Oct 23, 1992
- Date Received
- Jun 5, 1992
- 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)