510(k) K990020
K990020 is an FDA 510(k) premarket notification submitted by Te ME NA S.A.R.L. for the device "TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC". The FDA issued a decision of Substantially Equivalent on June 24, 1999. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Te ME NA S.A.R.L. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1999
- Date Received
- January 4, 1999
- 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