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FDA 510(k) Application Details - K000795
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K000795
Device Name
Lens, Contact (Other Material) - Daily
Applicant
POLYMER TECHNOLOGY
1400 N GOODMAN ST.
ROCHESTER, NY 14692 US
Other 510(k) Applications for this Company
Contact
DEBRA L.B. KETCHUM
Other 510(k) Applications for this Contact
Regulation Number
886.5916
More FDA Info for this Regulation Number
Classification Product Code
HQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/13/2000
Decision Date
05/26/2000
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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