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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 K012553
Device Name GSIBP BLOOD PRESSURE CUFF
Applicant
Globalshop, Inc.
1156 E. Ridgewood Ave.
P.O. Box 1211
Ridgewood,  NJ  07450
Applicant Contact GARY C BAUMAN
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/08/2001
Decision Date 08/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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