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 Garment, Protective, For Incontinence
510(k) Number K781930
Device Name PANT LINER, DISP. INCONTINENT
Applicant
FIBRE FORMATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FIBRE FORMATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received11/15/1978
Decision Date 02/01/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-