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 Catheter, Intravascular, Diagnostic
510(k) Number K942482
Device Name PRESSURE MONITORING EXTENSION
Applicant
Surgical Technologies, Inc.
2801 S. Decker Lake Ln.
Salt Lake City,  UT  84119
Applicant Contact JOHN E LINCOLN
Correspondent
Surgical Technologies, Inc.
2801 S. Decker Lake Ln.
Salt Lake City,  UT  84119
Correspondent Contact JOHN E LINCOLN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/25/1994
Decision Date 06/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-