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 Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K924200
Device Name REFLEX(R) ESC
Applicant
Richard-Allan Medical Ind., Inc.
8850m89, Box 351
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Richard-Allan Medical Ind., Inc.
8850m89, Box 351
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number884.4160
Classification Product Code
KNF  
Date Received08/20/1992
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-