510(k) K892868

KALTOSTAT WOUND PACKING by Calgon Vestal Div. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
April 19, 1989
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