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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 K952825
Device Name CUFF GUARD
Applicant
Bowen Medical Services, Inc.
1525 N. Ohio Ave.
Suite 6
Live Oak,  FL  32060
Applicant Contact H. CLAY WILSON
Correspondent
Bowen Medical Services, Inc.
1525 N. Ohio Ave.
Suite 6
Live Oak,  FL  32060
Correspondent Contact H. CLAY WILSON
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received06/20/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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