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FDA 510(k) Application Details - K981116
Device Classification Name
Device, Irrigation, Ocular Surgery
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510(K) Number
K981116
Device Name
Device, Irrigation, Ocular Surgery
Applicant
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE, CA 92623-9534 US
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Contact
MARCIA S YAROSS, PH,D.
Other 510(k) Applications for this Contact
Regulation Number
886.4360
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Classification Product Code
KYG
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More FDA Info for this Product Code
Date Received
03/27/1998
Decision Date
05/19/1998
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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