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 K922114
Device Name ENDOSCOPIC RETRIEVAL BASKET
Applicant
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact STEPHEN A SOSNOWSKI
Correspondent
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact STEPHEN A SOSNOWSKI
Regulation Number876.4680
Classification Product Code
FFL  
Date Received05/05/1992
Decision Date 08/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-