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FDA 510(k) Application Details - K963219
Device Classification Name
Implant, Orbital, Extra-Ocular
More FDA Info for this Device
510(K) Number
K963219
Device Name
Implant, Orbital, Extra-Ocular
Applicant
FCI OPHTHALMICS, INC.
P.O. BOX 465
76 PROSPECT ST.
MARSHFIELD HILLS, MA 02051 US
Other 510(k) Applications for this Company
Contact
ANNE BOHSACK
Other 510(k) Applications for this Contact
Regulation Number
886.3340
More FDA Info for this Regulation Number
Classification Product Code
HQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/1996
Decision Date
10/28/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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