FDA 510(k) Application Details - K071081

Device Classification Name Case, Contact Lens

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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
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Contact Diana Hong
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Regulation Number 886.5928

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Classification Product Code LRX
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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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