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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K850820
Device Name PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
Applicant
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Applicant Contact CHARLES M COOPERBER
Correspondent
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Correspondent Contact CHARLES M COOPERBER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/28/1985
Decision Date 04/10/1985
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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