FDA 510(k) Application Details - K003079

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K003079
Device Name Lenses, Soft Contact, Daily Wear
Applicant SPECIALTY TINT
1325 PROGRESS DR.
FRONT ROYAL, VA 22630 US
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Contact ROBERT BREECE
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 10/03/2000
Decision Date 11/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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