510(k) K973507

KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code FRO

Clearance Details

Decision
SN ()
Decision Date
December 15, 1997
Date Received
September 16, 1997
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