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 Lavage, Jet
510(k) Number K922083
Device Name RMI SURGICCAL SITE VISUALIZATION WAND
Applicant
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact RD HIBBERT
Correspondent
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact RD HIBBERT
Regulation Number880.5475
Classification Product Code
FQH  
Date Received05/04/1992
Decision Date 01/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-