510(k) K082042

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

K082042 is an FDA 510(k) premarket notification submitted by Zhejiang Gongdong Medical Plastic Factory for the device "GONGDONG DISPOSABLE SHARP CONTAINER". The FDA issued a decision of Substantially Equivalent on September 3, 2008. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Zhejiang Gongdong Medical Plastic Factory has at least 1 other 510(k) clearance on record.

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