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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 K900838
Device Name TRANSVAGINAL TRANSDUCER ASSEMBLY
Applicant
PIE MEDICAL EQUIPMENT B.V.
PHILIPSWEG 1
MAASTRICHT,  NL 6227 AJ
Applicant Contact RIKERS
Correspondent
PIE MEDICAL EQUIPMENT B.V.
PHILIPSWEG 1
MAASTRICHT,  NL 6227 AJ
Correspondent Contact RIKERS
Regulation Number884.2960
Classification Product Code
HGL  
Date Received02/22/1990
Decision Date 05/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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