FDA 510(k) Application Details - K003526

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K003526
Device Name Lenses, Soft Contact, Daily Wear
Applicant SPECIALTY ULTRAVISION, INC.
307 ORCHARD CITY DR.
SUITE 100
CAMPBELL, CA 95008 US
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Contact GAROLD L EDWARDS
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 11/16/2000
Decision Date 02/12/2001
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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