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510(k) K140947

COMPAT ENTERAL DELIVERY PUMP SETS by Nestle Healthcare Nutrition, Inc. — Product Code PIF

K140947 is an FDA 510(k) premarket notification submitted by Nestle Healthcare Nutrition, Inc. for the device "COMPAT ENTERAL DELIVERY PUMP SETS". The FDA issued a decision of Substantially Equivalent on September 4, 2014. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2014
Date Received
April 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

To facilitate enteral specific connections.

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FDA data resources