FDA 510(k) Application Details - K971618

Device Classification Name Case, Contact Lens

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510(K) Number K971618
Device Name Case, Contact Lens
Applicant ALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134 US
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Contact MICHEAL E PFLEGER
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 05/02/1997
Decision Date 07/14/1997
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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