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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K993623
Device Name GEMINI E
Applicant
Allen Medical Instruments Corp.
505 Superior Ave.
Newport Beach,  CA  92663
Applicant Contact JUDITH ALLEN
Correspondent
Allen Medical Instruments Corp.
505 Superior Ave.
Newport Beach,  CA  92663
Correspondent Contact JUDITH ALLEN
Regulation Number870.1875
Classification Product Code
DQD  
Date Received10/26/1999
Decision Date 06/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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