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 Collector, Ostomy
510(k) Number K842119
Device Name OSTOMY OR UROSTOMY ABDOMINAL BELT OS
Applicant
Atlas Surgical Belt Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Atlas Surgical Belt Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5900
Classification Product Code
EXB  
Date Received05/23/1984
Decision Date 09/10/1984
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
-
-