FDA 510(k) Application Details - K050517

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K050517
Device Name Accessories, Soft Lens Products
Applicant SZABOCSIK AND ASSOCIATES
203 N.WABASH, SUITE 1200
CHICAGO, IL 60601 US
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Contact JOHN MSZABOCSIK
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 03/01/2005
Decision Date 04/13/2005
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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