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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 K903379
Device Name PYMAH PRE-GAGED BALANCED TEMPA-KUFF
Applicant
Pymah Corp.
8904 Paddock Ln.
Potomac,  MD  20854
Applicant Contact L KONOPKO
Correspondent
Pymah Corp.
8904 Paddock Ln.
Potomac,  MD  20854
Correspondent Contact L KONOPKO
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/30/1990
Decision Date 10/19/1990
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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