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 Marker, Suture Identification
510(k) Number K896472
Device Name KEY VASCULAR BOOTIES
Applicant
Key Surgical, Inc.
7101 York Ave. S.
Minneapolis,  MN  55435 -4450
Applicant Contact KAY NORDBYE
Correspondent
Key Surgical, Inc.
7101 York Ave. S.
Minneapolis,  MN  55435 -4450
Correspondent Contact KAY NORDBYE
Regulation Number878.4800
Classification Product Code
MAW  
Date Received11/13/1989
Decision Date 12/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-