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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 K854752
Device Name THE CALIFORNIA SPLINT
Applicant
Intl. Medication Systems, Ltd.
1886 Santa Anita Ave.,
South El Monte,  CA  91733
Applicant Contact DIANE GILLETT
Correspondent
Intl. Medication Systems, Ltd.
1886 Santa Anita Ave.,
South El Monte,  CA  91733
Correspondent Contact DIANE GILLETT
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received11/26/1985
Decision Date 12/17/1985
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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