510(k) K080600
K080600 is an FDA 510(k) premarket notification submitted by Ultimed, Inc. for the device "ULTIMED ULTICARE SAFETY SYRINGE". The FDA issued a decision of Substantially Equivalent on Jun 25, 2008. The device falls under product code MEG (Syringe, Antistick), 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
- Jun 25, 2008
- Date Received
- Mar 3, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)