FDA 510(k) Application Details - K082042

Device Classification Name Container, Sharps

  More FDA Info for this Device
510(K) Number K082042
Device Name Container, Sharps
Applicant ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
BEICHENG INDUSTRIAL AREA
HUANGYAN, TAIZHOU, ZHEJIANG 318020 CN
Other 510(k) Applications for this Company
Contact WEIFENG ZHONG
Other 510(k) Applications for this Contact
Regulation Number 880.5570

  More FDA Info for this Regulation Number
Classification Product Code MMK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/18/2008
Decision Date 09/03/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact