510(k) K160190
K160190 is an FDA 510(k) premarket notification submitted by Sunny Medical Device (Shenzhen) Co., Ltd. for the device "Sunmed Control Syringes". The FDA issued a decision of Substantially Equivalent on November 10, 2016. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Sunny Medical Device (Shenzhen) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2016
- Date Received
- January 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type