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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Obstetric
510(k) Number K901142
Device Name MER MULTIPLANE VAGINAL PROBE (MVP)
Applicant
Medical Equipment Resources
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
Medical Equipment Resources
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact GARY J ALLSEBROOK
Regulation Number884.2960
Classification Product Code
HGL  
Date Received03/12/1990
Decision Date 08/22/1990
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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