FDA 510(k) Application Details - K150986

Device Classification Name Weights, Eyelid, External

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510(K) Number K150986
Device Name Weights, Eyelid, External
Applicant MEDDEV CORPORATION
730 NORTH PASTORIA AVE
SUNNYVALE, CA 94085 US
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Contact PATRICK GREY
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Regulation Number 000.0000

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Classification Product Code MML
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Date Received 04/14/2015
Decision Date 08/17/2015
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 N
Expedited Review



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