510(k) K901853

MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS by Johnson & Johnson Medical, Inc. — Product Code NAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1991
Date Received
April 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type