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 K840113
Device Name SILICONE SPLINTING MATERIAL
Applicant
General Dental Products, Inc.
2281 Devon Ave.
Elk Grove Village,  IL  60007
Applicant Contact JED A PEELER
Correspondent
General Dental Products, Inc.
2281 Devon Ave.
Elk Grove Village,  IL  60007
Correspondent Contact JED A PEELER
Regulation Number878.4025
Classification Product Code
MDA  
Date Received01/11/1984
Decision Date 04/17/1985
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
Predetermined Change
Control Plan Authorized		 No
-
-