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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K963987
Device Name CAMOUFLAGE CUFF SAVERS
Applicant
N.A. Braggs Medical, Inc.
8255 Brackett Ln.
Semmes,  AL  36575
Applicant Contact JACQUELINE BRACKETT
Correspondent
N.A. Braggs Medical, Inc.
8255 Brackett Ln.
Semmes,  AL  36575
Correspondent Contact JACQUELINE BRACKETT
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/04/1996
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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