510(k) K991818

ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 by Acrymed, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2000
Date Received
May 27, 1999
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