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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K921853
Device Name 4 SURE TM FEEDING TUBES
Applicant
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Applicant Contact RANDALL GREEN
Correspondent
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Correspondent Contact RANDALL GREEN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/17/1992
Decision Date 07/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-