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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 K092604
Device Name LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX
Applicant
Trimline Medical Products Corp.
34 Columbia Ave.
Branchburg,  NJ  08876
Applicant Contact NANCY SKOCYPEC
Correspondent
Trimline Medical Products Corp.
34 Columbia Ave.
Branchburg,  NJ  08876
Correspondent Contact NANCY SKOCYPEC
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/25/2009
Decision Date 10/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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