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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 K792355
Device Name ANEROID SPHYMOMANOMETER
Applicant
ABCO DEALERS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ABCO DEALERS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received11/21/1979
Decision Date 12/05/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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