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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K971067
Device Name DIGI-INJECTOR
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
14477 CATALINA ST.
SAN LEANDRO,  CA  94577
Applicant Contact JULIAN CORTELLA
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
14477 CATALINA ST.
SAN LEANDRO,  CA  94577
Correspondent Contact JULIAN CORTELLA
Regulation Number880.5725
Classification Product Code
MRH  
Date Received03/24/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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