FDA 510(k) Application Details - K983973

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K983973
Device Name Accessories, Soft Lens Products
Applicant ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 US
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Contact MICHAEL PFLEGER
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 11/09/1998
Decision Date 12/18/1998
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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