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510(k) K161811

Medela Low Dose Enteral Syringe by Medela, Inc. — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2017
Date Received
July 1, 2016
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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