510(k) K990530

KERLIX MD ANTIMICROBIAL GAUZE DRESSING by The Kendall Company, L.P. — Product Code NAD

K990530 is an FDA 510(k) premarket notification submitted by The Kendall Company, L.P. for the device "KERLIX MD ANTIMICROBIAL GAUZE DRESSING". The FDA issued a decision of Substantially Equivalent on January 31, 2000. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. The Kendall Company, L.P. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2000
Date Received
February 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type