510(k) K854063

MICROVASIVE SILICONE SPRAY by Microvasive — Product Code KCT

K854063 is an FDA 510(k) premarket notification submitted by Microvasive for the device "MICROVASIVE SILICONE SPRAY". The FDA issued a decision of Substantially Equivalent on October 25, 1985. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Microvasive has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1985
Date Received
October 4, 1985
Clearance Type
Traditional
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