510(k) K933469
K933469 is an FDA 510(k) premarket notification submitted by Univec, Inc. for the device "UNIVEC NON-REUSABLE SYRINGE". The FDA issued a decision of Substantially Equivalent on April 18, 1996. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Univec, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1996
- Date Received
- July 16, 1993
- 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