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 cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K923995
Device Name URODYNAMICS TUBING KITS #5161, #5150, #7170
Applicant
ADVANCED MEDICAL PRODUCTS, INC.
P.O. BOX 10040
MERRILLVILLE,  IN  46411
Applicant Contact JOEL J ROSEN
Correspondent
ADVANCED MEDICAL PRODUCTS, INC.
P.O. BOX 10040
MERRILLVILLE,  IN  46411
Correspondent Contact JOEL J ROSEN
Regulation Number876.1620
Classification Product Code
FAP  
Date Received08/10/1992
Decision Date 04/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-