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 Chair, Ophthalmic, Ac-Powered
510(k) Number K863008
Device Name -OM WEST 2000 GNATUS CHAIR
Applicant
Sds Dental, Inc.
4321 Wisconsin Ave. N.W
Suite 200
Washington,  DC  20016
Applicant Contact CESAR CORAL
Correspondent
Sds Dental, Inc.
4321 Wisconsin Ave. N.W
Suite 200
Washington,  DC  20016
Correspondent Contact CESAR CORAL
Regulation Number886.1140
Classification Product Code
HME  
Date Received08/08/1986
Decision Date 09/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-