510(k) K950897

BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) by Biosystems — Product Code MMK

K950897 is an FDA 510(k) premarket notification submitted by Biosystems for the device "BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Biosystems has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
February 27, 1995
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