510(k) K983430
K983430 is an FDA 510(k) premarket notification submitted by Medicore, Inc. for the device "LITE-TOUCH SYRINGE". The FDA issued a decision of Substantially Equivalent on Feb 9, 1999. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Medicore, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 1999
- Date Received
- Sep 29, 1998
- 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
- 510(k)