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FDA 510(k) Application Details - K130997
Device Classification Name
More FDA Info for this Device
510(K) Number
K130997
Device Name
NEOVEIL
Applicant
GUNZE LIMITED
46 NATSUMEGAICHI, AONO
AYABE, KYOTO 623-8513 JP
Other 510(k) Applications for this Company
Contact
NOBUYA ONISHI
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2013
Decision Date
11/15/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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