FDA 510(k) Application Details - K003109

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K003109
Device Name Accessories, Soft Lens Products
Applicant ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE, CA 92623-9534 US
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Contact PAUL J NOWACKI
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 10/04/2000
Decision Date 11/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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