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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K932973
Device Name ROYL-DERM WOUND HYDROGEL DRESSING
Applicant
Renaissance Medical, Inc.
33971 Selva
Suite 100
Dana Point,  CA  92629
Applicant Contact DARLENE MCCORD
Correspondent
Renaissance Medical, Inc.
33971 Selva
Suite 100
Dana Point,  CA  92629
Correspondent Contact DARLENE MCCORD
Classification Product Code
MGQ  
Date Received06/14/1993
Decision Date 01/10/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-