FDA 510(k) Application Details - K030548

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K030548
Device Name Lenses, Soft Contact, Daily Wear
Applicant ST. SHINE OPTICAL CO., LTD.
2091 UPPER SCENIC DR.
FELTON, CA 95018 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 02/20/2003
Decision Date 04/04/2003
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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