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 K840723
Device Name SWEEN-A-PEEL PERISTOMAL WAFERS
Applicant
Sween Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sween Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5900
Classification Product Code
EXB  
Date Received02/21/1984
Decision Date 05/07/1984
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
-
-