510(k) K990530
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