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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sound, Uterine
510(k) Number K884684
Device Name ROCKET INTRAUTERINE DEPTH SOUND
Applicant
A & A MEDICAL, INC.
31A BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact CEDRIC K BERNBERG
Correspondent
A & A MEDICAL, INC.
31A BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact CEDRIC K BERNBERG
Regulation Number884.4530
Classification Product Code
HHM  
Date Received11/08/1988
Decision Date 12/20/1988
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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