• 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 collector, ostomy
510(k) Number K140938
Device Name OSTOM-I ALERT
Applicant
11 HEALTH AND TECHNOLOGIES LLC
1468 Harwell Avenue
crofton,  MD  21114
Applicant Contact e j smith
Correspondent
11 HEALTH AND TECHNOLOGIES LLC
1468 Harwell Avenue
crofton,  MD  21114
Correspondent Contact e j smith
Regulation Number876.5900
Classification Product Code
EXB  
Subsequent Product Codes
EZQ   EZS  
Date Received04/11/2014
Decision Date 10/10/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-