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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 K925744
Device Name TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
Applicant
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Applicant Contact ROBERT A LANG
Correspondent
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Correspondent Contact ROBERT A LANG
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received11/13/1992
Decision Date 07/30/1993
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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