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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name source, carrier, fiberoptic light
510(k) Number K932131
Device Name MID LABS TWIN ILLUMINATOR
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
2235 POLVOROSA AVE.
SUITE 200
SAN LEANDRO,  CA  94577
Applicant Contact DAVID E CHEN
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
2235 POLVOROSA AVE.
SUITE 200
SAN LEANDRO,  CA  94577
Correspondent Contact DAVID E CHEN
Regulation Number874.4350
Classification Product Code
EQH  
Date Received05/03/1993
Decision Date 04/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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