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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K850184
Device Name MEDICAL MULTI-IMAGE CAMERA-676
Applicant
Dunn Instruments, Inc.
544 Second St.
San Francisco,  CA  94107
Applicant Contact JOHN LEITE
Correspondent
Dunn Instruments, Inc.
544 Second St.
San Francisco,  CA  94107
Correspondent Contact JOHN LEITE
Regulation Number892.2040
Classification Product Code
LMC  
Date Received01/18/1985
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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