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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 K934180
Device Name SLIMLINE 3000
Applicant
PYMAH CORP.
8904 PADDOCK LN.
POTOMAC,  MD  20854
Applicant Contact BERNARD KONOPKO
Correspondent
PYMAH CORP.
8904 PADDOCK LN.
POTOMAC,  MD  20854
Correspondent Contact BERNARD KONOPKO
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/27/1993
Decision Date 11/24/1993
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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