FDA 510(k) Application Details - K001235

Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable

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510(K) Number K001235
Device Name Products, Contact Lens Care, Rigid Gas Permeable
Applicant ALCON UNIVERSAL, LTD.
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099 US
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Contact RALPH H LARSON
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Regulation Number 886.5918

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Classification Product Code MRC
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Date Received 04/17/2000
Decision Date 07/03/2000
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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