510(k) K851523
K851523 is an FDA 510(k) premarket notification submitted by Transcoject GmbH & Co. KG for the device "DISPOSABLE PLASTIC SYRINGES". The FDA issued a decision of Substantially Equivalent on Jul 24, 1985. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 1985
- Date Received
- Apr 16, 1985
- 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)