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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 K861984
Device Name UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
Applicant
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Applicant Contact CHARLES COPPERBERG
Correspondent
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Correspondent Contact CHARLES COPPERBERG
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/22/1986
Decision Date 08/05/1986
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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