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 K844503
Device Name UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
Applicant
Epcom Medical Systems, Inc.
26602 Corporate Ave.
Hayward,  CA  94545
Applicant Contact PAUL ULBRICH
Correspondent
Epcom Medical Systems, Inc.
26602 Corporate Ave.
Hayward,  CA  94545
Correspondent Contact PAUL ULBRICH
Regulation Number876.1620
Classification Product Code
FAP  
Date Received11/20/1984
Decision Date 01/02/1985
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
-
-