510(k) K063666

SHARPS CONTAINER, MODEL 039-413 by Biodex Medical Systems, Inc. — Product Code MMK

K063666 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "SHARPS CONTAINER, MODEL 039-413". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
December 11, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type