510(k) K853334

NON-ADHERA ADHESIVE PAD 3X4 by American White Cross, Inc. — Product Code NAD

K853334 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "NON-ADHERA ADHESIVE PAD 3X4". The FDA issued a decision of Substantially Equivalent on August 21, 1985. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
August 9, 1985
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