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 Cover, Shoe, Operating-Room
510(k) Number K861528
Device Name TECNOL PERSONAL SHOE COVER
Applicant
Technol, Inc.
7450 Whitehall
Fort Worth,  TX  76118
Applicant Contact DAVID ARCHER
Correspondent
Technol, Inc.
7450 Whitehall
Fort Worth,  TX  76118
Correspondent Contact DAVID ARCHER
Regulation Number878.4040
Classification Product Code
FXP  
Date Received04/24/1986
Decision Date 05/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-