510(k) K172694

Sterile Disposable Syringes by Shenyang Mastech Medical Device Co., Ltd. — Product Code DXT

K172694 is an FDA 510(k) premarket notification submitted by Shenyang Mastech Medical Device Co., Ltd. for the device "Sterile Disposable Syringes". The FDA issued a decision of Substantially Equivalent on Jul 6, 2018. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 6, 2018
Date Received
Sep 7, 2017
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
510(k)