FDA 510(k) Application Details - K984273

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K984273
Device Name Lens, Contact, (Disposable)
Applicant CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH, GA 30097 US
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Contact STEVEN DOWDLEY
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Regulation Number 886.5925

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Classification Product Code MVN
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Date Received 11/30/1998
Decision Date 01/25/1999
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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