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FDA 510(k) Application Details - K962112
Device Classification Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
More FDA Info for this Device
510(K) Number
K962112
Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Applicant
LENS COMFORT, INC.
912 BROAD ST.
ELIZABETH, NJ 07208 US
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Contact
JAMES DEMESTICHAS
Other 510(k) Applications for this Contact
Regulation Number
886.5928
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Classification Product Code
LYL
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More FDA Info for this Product Code
Date Received
05/31/1996
Decision Date
11/29/1996
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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