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510(k) K181426

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) by Jiangsu Micsafe Medical Technology Co., Ltd. — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2018
Date Received
May 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Syringes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

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