FDA 510(k) Application Details - K974281

Device Classification Name Case, Contact Lens

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510(K) Number K974281
Device Name Case, Contact Lens
Applicant ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 US
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Contact RALPH H LARSEN
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 11/14/1997
Decision Date 01/20/1998
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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