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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K951393
Device Name ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
Applicant
Solomon Technology Labs
2726 W. Montgomery Dr.
Chandler,  AZ  85224
Applicant Contact DANZIL K SOLOMON
Correspondent
Solomon Technology Labs
2726 W. Montgomery Dr.
Chandler,  AZ  85224
Correspondent Contact DANZIL K SOLOMON
Regulation Number884.2225
Classification Product Code
HEM  
Date Received03/27/1995
Decision Date 05/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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