510(k) K973509

KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code KMF

K973509 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING". The FDA issued a decision of SN on December 4, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Kendall Healthcare Products Co. Div.Of Tyco Health has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 4, 1997
Date Received
September 16, 1997
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