510(k) K170651
K170651 is an FDA 510(k) premarket notification submitted by Yangzhou Medline Industry, Co., Ltd. for the device "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle". The FDA issued a decision of Substantially Equivalent on August 2, 2017. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Yangzhou Medline Industry, Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2017
- Date Received
- March 3, 2017
- 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