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 Elastomer, Silicone, For Scar Management
510(k) Number K973572
Device Name KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
Applicant
Hanson Medical, Inc.
P.O. Box 1160
Kingston,  WA  98346
Applicant Contact ERIK HANSON
Correspondent
Hanson Medical, Inc.
P.O. Box 1160
Kingston,  WA  98346
Correspondent Contact ERIK HANSON
Regulation Number878.4025
Classification Product Code
MDA  
Date Received09/19/1997
Decision Date 10/21/1997
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
-
-