FDA 510(k) Application Details - K984046

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K984046
Device Name Lenses, Soft Contact, Daily Wear
Applicant OCULAR SCIENCES PUERTO RICO, INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact RICHARD E LIPPMAN
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 11/12/1998
Decision Date 01/21/1999
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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