510(k) K951918
K951918 is an FDA 510(k) premarket notification submitted by Surgical Technologies, Inc. for the device "SURGICAL TECHNOLOGIES, INC. SYRINGE". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Surgical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1995
- Date Received
- April 24, 1995
- 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