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FDA 510(k) Application Details - K130742
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K130742
Device Name
Vinyl Patient Examination Glove
Applicant
DAHOON PLASTIC CO., LTD.
ROOM 1606 BLDG. 1 JIANXIANG YUAN NO.209
BEI SI HUAN ZHONG RD, HAIDIAN DIS
BEIJING 100083 CN
Other 510(k) Applications for this Company
Contact
CHU XIAOAN
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
03/19/2013
Decision Date
09/10/2014
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
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