510(k) K894802

AWC BUTTERFLY WOUND CLOSURES by American White Cross, Inc. — Product Code FPX

K894802 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "AWC BUTTERFLY WOUND CLOSURES". The FDA issued a decision of Substantially Equivalent on January 31, 1990. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1990
Date Received
July 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Adhesive, Closure, Skin
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type