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 tray, surgical, instrument
510(k) Number K910328
Device Name KEY COMFORT GRIPS
Applicant
KEY SURGICAL, INC.
7101 YORK AVENUE SOUTH
MINNEAPOLIS,  MN  55435 -4450
Applicant Contact KAY NORDBYE
Correspondent
KEY SURGICAL, INC.
7101 YORK AVENUE SOUTH
MINNEAPOLIS,  MN  55435 -4450
Correspondent Contact KAY NORDBYE
Regulation Number878.4800
Classification Product Code
FSM  
Date Received01/25/1991
Decision Date 03/06/1991
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
-
-