• 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 Bag, Bile Collecting
510(k) Number K990428
Device Name DRAINAGE BAG
Applicant
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA,  GA  30005
Applicant Contact STEVE WOODY
Correspondent
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA,  GA  30005
Correspondent Contact STEVE WOODY
Regulation Number876.5010
Classification Product Code
EXF  
Date Received02/11/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-