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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K851009
Device Name INFUSION SLEEVE - OPHTHALMIC
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
2235 POLVOROSA AVE.
SUITE 200
SAN LEANDRO,  CA  94577
Applicant Contact WILLIAM T GEORGE
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
2235 POLVOROSA AVE.
SUITE 200
SAN LEANDRO,  CA  94577
Correspondent Contact WILLIAM T GEORGE
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/12/1985
Decision Date 04/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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