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FDA 510(k) Application Details - K023481
Device Classification Name
Implant, Orbital, Extra-Ocular
More FDA Info for this Device
510(K) Number
K023481
Device Name
Implant, Orbital, Extra-Ocular
Applicant
MICROVISION, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
SHEILA HEMEON-HEYER, JD, RAC
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
10/17/2002
Decision Date
01/08/2003
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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