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FDA 510(k) Application Details - K963377
Device Classification Name
Speculum, Vaginal, Nonmetal
More FDA Info for this Device
510(K) Number
K963377
Device Name
Speculum, Vaginal, Nonmetal
Applicant
NORTH EOS INDUSTRIES, INC.
54, LANE 1, BEEN ST.
TUNG-SHIH
TAICHUNG HSIEN TW
Other 510(k) Applications for this Company
Contact
SARA CHEN
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/1996
Decision Date
10/04/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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