510(k) K082042

GONGDONG DISPOSABLE SHARP CONTAINER by Zhejiang Gongdong Medical Plastic Factory — Product Code MMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2008
Date Received
July 18, 2008
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