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FDA 510(k) Application Details - K122266
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K122266
Device Name
Vinyl Patient Examination Glove
Applicant
SHANDONG JUNFENG INDUSTRIES CO., LTD
ROOM 1606 BLDG. 1. JIANXIANG YUAN
BO. 209 BEI SI HUAN
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
07/30/2012
Decision Date
09/27/2012
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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