510(k) K952420

STERIGAUZE WET DRESSING by Acacia Laboratories, Inc. — Product Code KMF

K952420 is an FDA 510(k) premarket notification submitted by Acacia Laboratories, Inc. for the device "STERIGAUZE WET DRESSING". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Acacia Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1995
Date Received
May 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type