510(k) K941176

ALGINATE FIBER by Adri/Technam — Product Code KMF

K941176 is an FDA 510(k) premarket notification submitted by Adri/Technam for the device "ALGINATE FIBER". The FDA issued a decision of SN on July 28, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Adri/Technam has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 28, 1994
Date Received
March 14, 1994
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