510(k) K915676
K915676 is an FDA 510(k) premarket notification submitted by Chathamborough Research Group, Inc. for the device "SPLATTER SHIELD". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Chathamborough Research Group, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1992
- Date Received
- December 19, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type