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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, orbital, extra-ocular
510(k) Number K023481
Device Name MICROVISION SCLERAL BUCKLING COMPONENTS
Applicant
MICROVISION, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER, JD, RAC
Correspondent
MICROVISION, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER, JD, RAC
Regulation Number886.3340
Classification Product Code
HQX  
Date Received10/17/2002
Decision Date 01/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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