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 Accessories, Pump, Infusion
510(k) Number K012266
Device Name SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
Applicant
National Custom Ent., Inc.
1133 E. Cliff Rd.
Burnsville,  MN  55337
Applicant Contact DON PELLETIER
Correspondent
National Custom Ent., Inc.
1133 E. Cliff Rd.
Burnsville,  MN  55337
Correspondent Contact DON PELLETIER
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
MOQ  
Date Received07/18/2001
Decision Date 09/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-