510(k) K984388

HA ABSORBENT WOUND DRESSING by Convatec, A Division of E.R. Squibb & Sons — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1999
Date Received
December 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type