FDA 510(k) Application Details - K032908

Device Classification Name Vinyl Patient Examination Glove

  More FDA Info for this Device
510(K) Number K032908
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
RM. 707, AVIC BLDG., NO.2
DONG SAN HUAN NAN ROAD
CHAOYANG DISTRICT; BEIJING 100022 CN
Other 510(k) Applications for this Company
Contact CHEN YUHONG
Other 510(k) Applications for this Contact
Regulation Number 880.6250

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

  More FDA Info for this Product Code
Date Received 09/17/2003
Decision Date 11/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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