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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name products, contact lens care, rigid gas permeable
510(k) Number K983836
Device Name RIGID GAS PERMEABLE CONTACT LENS SOLUTION
Original Applicant
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
1400 north goodman st.
rochester,  NY  14692
Original Contact debra l.b. ketchum
Regulation Number886.5918
Classification Product Code
MRC  
Date Received10/30/1998
Decision Date 02/11/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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