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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 K945035
Device Name OCL CONTOUR
Applicant
M-Pact Worldwide, LLC
1040 Ocl Pkwy.
P.O. Box 618
Eudora,  KS  66025
Applicant Contact GARY D NUTT
Correspondent
M-Pact Worldwide, LLC
1040 Ocl Pkwy.
P.O. Box 618
Eudora,  KS  66025
Correspondent Contact GARY D NUTT
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/13/1994
Decision Date 11/15/1994
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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