510(k) K932602

ADHESIVE BANDAGES by Aso Corp. — Product Code KGX

K932602 is an FDA 510(k) premarket notification submitted by Aso Corp. for the device "ADHESIVE BANDAGES". The FDA issued a decision of Substantially Equivalent on August 9, 1993. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Aso Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
May 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type