Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K140947
Device Name COMPAT ENTERAL DELIVERY PUMP SETS
Applicant
Nestle Healthcare Nutrition, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact M.W.(ANDY) ANDERSON
Correspondent
Nestle Healthcare Nutrition, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact M.W.(ANDY) ANDERSON
Regulation Number876.5980
Classification Product Code
PIF  
Date Received04/14/2014
Decision Date 09/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-