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 K885185
Device Name INTERA SHIELD AND INTERA UNDERGARMENT
Applicant
INTERA CORP.
P.O. BOX 25376
CHATTANOOGA,  TN  37422 -5376
Applicant Contact LARRY ENGLISH
Correspondent
INTERA CORP.
P.O. BOX 25376
CHATTANOOGA,  TN  37422 -5376
Correspondent Contact LARRY ENGLISH
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received12/14/1988
Decision Date 02/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-