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 Dressing, Wound, Drug
510(k) Number K980777
Device Name DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
Applicant
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact SHARMINI ATHERAY, M.SC
Correspondent
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact SHARMINI ATHERAY, M.SC
Classification Product Code
FRO  
Date Received03/02/1998
Decision Date 05/04/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-