510(k) K160589
K160589 is an FDA 510(k) premarket notification submitted by Certa Dose, Inc. for the device "Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe". The FDA issued a decision of Substantially Equivalent on Jan 19, 2017. The device falls under product code PQX (Epinephrine Syringe), a Class II device regulated under 21 CFR 880.5860. Certa Dose, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 2017
- Date Received
- Mar 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Epinephrine Syringe
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)
Intended for intramuscular or subcutaneous injection of epinephrine.