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 K950132
Device Name DUMEX WET DRESSINGS
Applicant
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact ANGELO GUERRIERO
Correspondent
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact ANGELO GUERRIERO
Classification Product Code
FRO  
Date Received01/13/1995
Decision Date 03/01/1995
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
-
-