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 Gauze/Sponge, Internal
510(k) Number K961061
Device Name CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
Applicant
Codi International BV
One Beacon St.
Boston,  MA  02108
Applicant Contact G. THACHER STORM
Correspondent
Codi International BV
One Beacon St.
Boston,  MA  02108
Correspondent Contact G. THACHER STORM
Classification Product Code
EFQ  
Date Received03/18/1996
Decision Date 06/06/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-