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FDA 510(k) Application Details - K980591
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K980591
Device Name
Accessories, Soft Lens Products
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact
KIM S DEVITTO
Other 510(k) Applications for this Contact
Regulation Number
886.5928
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Classification Product Code
LPN
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More FDA Info for this Product Code
Date Received
02/17/1998
Decision Date
06/24/1998
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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