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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 K860234
Device Name TRANSVAGINAL TRANSDUCER, 5MHZ
Applicant
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Applicant Contact ROBERT F AVRUTIK
Correspondent
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Correspondent Contact ROBERT F AVRUTIK
Regulation Number884.2960
Classification Product Code
HGL  
Date Received01/22/1986
Decision Date 05/23/1986
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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