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 Accessory, Surgical Apparel
510(k) Number K940723
Device Name BODY BOOT
Applicant
Mark-Clark
3601 W. 29th St.
Topka,  KS  66614
Applicant Contact KEN WEDDLE
Correspondent
Mark-Clark
3601 W. 29th St.
Topka,  KS  66614
Correspondent Contact KEN WEDDLE
Regulation Number878.4040
Classification Product Code
LYU  
Date Received02/18/1994
Decision Date 09/06/1994
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
-
-