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FDA 510(k) Application Details - K072314
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K072314
Device Name
Vinyl Patient Examination Glove
Applicant
XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
BIHE INDUSTRY AREA
YITANG TOWN, PIZHOU COUNTY
JIANGSU CN
Other 510(k) Applications for this Company
Contact
HSUN- HUI HUANG
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
08/17/2007
Decision Date
12/12/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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