510(k) K994230
K994230 is an FDA 510(k) premarket notification submitted by Ultimed, Inc. for the device "ULTICARE DISPOSABLE SYRINGE". The FDA issued a decision of Substantially Equivalent on Mar 24, 2000. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Ultimed, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2000
- Date Received
- Dec 16, 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
- 510(k)