FDA 510(k) Application Details - K961242

Device Classification Name Lens, Guide, Intraocular

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510(K) Number K961242
Device Name Lens, Guide, Intraocular
Applicant ALLERGAN, INC.
2525 DUPONT DR.
IRVINE, CA 92612 US
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Contact MAUREEN WEINER
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Regulation Number 886.4300

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Classification Product Code KYB
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Date Received 04/01/1996
Decision Date 06/17/1996
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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