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, X-Ray Detectable
510(k) Number K853742
Device Name GAUZE SPONGE
Applicant
South Mountain Medical
537 Sweeten Ck. Inc. Pk
Asheville,  NC  28803
Applicant Contact CLAIRE BRANCH
Correspondent
South Mountain Medical
537 Sweeten Ck. Inc. Pk
Asheville,  NC  28803
Correspondent Contact CLAIRE BRANCH
Regulation Number878.4450
Classification Product Code
GDY  
Date Received09/06/1985
Decision Date 10/08/1985
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
-
-