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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 K905000
Device Name ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
Applicant
COROMETRICS MEDICAL SYSTEMS, INC.
61 BARNES PARK RD. NORTH
P.O. BOX 333
WALLINGFORD,  CT  06492
Applicant Contact BRIAN R BARRY
Correspondent
COROMETRICS MEDICAL SYSTEMS, INC.
61 BARNES PARK RD. NORTH
P.O. BOX 333
WALLINGFORD,  CT  06492
Correspondent Contact BRIAN R BARRY
Regulation Number884.2225
Classification Product Code
HEM  
Date Received11/07/1990
Decision Date 01/31/1991
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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