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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Blood, Fetal
510(k) Number K884685
Device Name ROCKET FETAL BLOOD SAMPLING TRAY
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 Number884.1560
Classification Product Code
HGW  
Date Received11/08/1988
Decision Date 01/12/1989
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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