510(k) K090560

CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS by Conmed Linvatec — Product Code KCT

K090560 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS". The FDA issued a decision of Substantially Equivalent on June 29, 2009. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Conmed Linvatec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2009
Date Received
March 2, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type