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 K974251
Device Name X-CELL WOUND DRESSING
Applicant
Xylos Corporation
29 Ainsworth Ave.
East Burnswick,  NJ  08816
Applicant Contact ERIC FLAM
Correspondent
Xylos Corporation
29 Ainsworth Ave.
East Burnswick,  NJ  08816
Correspondent Contact ERIC FLAM
Classification Product Code
MGQ  
Date Received11/13/1997
Decision Date 06/22/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-