510(k) K945675

PREPPIES SKIN BARRIER WIPE by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
November 18, 1994
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