510(k) K974251

X-CELL WOUND DRESSING by Xylos Corporation — Product Code MGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1998
Date Received
November 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type