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FDA 510(k) Application Details - K180319
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K180319
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
Bausch and Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609 US
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Contact
Melissa Thomas
Other 510(k) Applications for this Contact
Regulation Number
886.5918
More FDA Info for this Regulation Number
Classification Product Code
MRC
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More FDA Info for this Product Code
Date Received
02/05/2018
Decision Date
03/27/2018
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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