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FDA 510(k) Application Details - K071081
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K071081
Device Name
Case, Contact Lens
Applicant
NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT
LANE 999, ZHONGSHAN NO. 2 ROAD
SUITE 8D, ZHONGXIN ZHONGSHAN B
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2007
Decision Date
05/01/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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