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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 K080189
Device Name TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX
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 Received01/25/2008
Decision Date 08/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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