510(k) K052992

CONMED LINVATEC INSTRUMENT STERILIZATION TRAY by Conmed Linvatec — Product Code FRG

K052992 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC INSTRUMENT STERILIZATION TRAY". The FDA issued a decision of Substantially Equivalent on October 16, 2006. The device falls under product code FRG (Wrap, Sterilization), 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
October 16, 2006
Date Received
October 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type