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FDA 510(k) Application Details - K974466
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K974466
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER, NY 14692 US
Other 510(k) Applications for this Company
Contact
DOGULAS J FORTUNATO
Other 510(k) Applications for this Contact
Regulation Number
886.5918
More FDA Info for this Regulation Number
Classification Product Code
MRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/1997
Decision Date
02/19/1998
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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