510(k) K874579
K874579 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "COEUR CONTROL SYRINGE". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Coeur Laboratories, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1988
- Date Received
- November 6, 1987
- 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