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 dislodger, stone, basket, ureteral, metal
510(k) Number K012581
Device Name REPROCESSED STONE RETRIEVAL BASKETS
Applicant
STERILMED, INC.
11400 73RD AVE N., SUITE 100
MAPLE GROVE,  MN  55369
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
STERILMED, INC.
11400 73RD AVE N., SUITE 100
MAPLE GROVE,  MN  55369
Correspondent Contact PATRICK FLEISCHHACKER
Regulation Number876.4680
Classification Product Code
FFL  
Date Received08/09/2001
Decision Date 02/14/2002
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
-
-