FDA 510(k) Application Details - K993486

Device Classification Name Case, Contact Lens

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510(K) Number K993486
Device Name Case, Contact Lens
Applicant PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA, AZ 85204 US
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Contact WILLIAM E MEYERS
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 10/15/1999
Decision Date 12/22/1999
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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