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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K870356
Device Name TATCH-IT
Applicant
Reunion Medical Co.
10311 Hauser Dr.R
Lenexa,  KS  66215
Applicant Contact JANET K SCHMUTZLER
Correspondent
Reunion Medical Co.
10311 Hauser Dr.R
Lenexa,  KS  66215
Correspondent Contact JANET K SCHMUTZLER
Regulation Number870.2850
Classification Product Code
DRS  
Date Received01/29/1987
Decision Date 06/12/1987
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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