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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K881796
Device Name UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE
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 Number870.4500
Classification Product Code
DWS  
Date Received04/27/1988
Decision Date 07/26/1988
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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