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 Operating Room Accessories Table Tray
510(k) Number K872900
Device Name THE PORTABLE ORDERLY
Applicant
EDGEWATER MEDICAL EQUIPMENT SYSTEMS
6263 MAYFIELD RD.
SUITE 206
MAYFIELD HTS.,  OH  44124
Applicant Contact DANIEL ALLEN
Correspondent
EDGEWATER MEDICAL EQUIPMENT SYSTEMS
6263 MAYFIELD RD.
SUITE 206
MAYFIELD HTS.,  OH  44124
Correspondent Contact DANIEL ALLEN
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received07/24/1987
Decision Date 08/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-