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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 K942259
Device Name TECHNICUFF
Applicant
TECHNICUFF CORP.
811 S. BOYLSTON ST.
LEESBURG,  FL  34748
Applicant Contact L. WILLIAM YANDELL
Correspondent
TECHNICUFF CORP.
811 S. BOYLSTON ST.
LEESBURG,  FL  34748
Correspondent Contact L. WILLIAM YANDELL
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received05/09/1994
Decision Date 09/06/1994
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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