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FDA 510(k) Application Details - K983836
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K983836
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14692 US
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DEBRA L.B. KETCHUM
Other 510(k) Applications for this Contact
Regulation Number
886.5918
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Classification Product Code
MRC
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More FDA Info for this Product Code
Date Received
10/30/1998
Decision Date
02/11/1999
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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