510(k) K050842

AGCEL WOUND DRESSING,AGCEL BURN DRESSING by Modern Medical Equipment Mfg., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2006
Date Received
April 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type