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 Angioscope
510(k) Number K934696
Device Name ANGIOSCOPE
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 Number876.1500
Classification Product Code
LYK  
Date Received09/30/1993
Decision Date 01/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-