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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K860168
Device Name UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
Applicant
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Applicant Contact M COPPERBERG
Correspondent
Universal Medical Instrument Corp.
Post Office Box 100
Ballston Spa,  NY  12020
Correspondent Contact M COPPERBERG
Date Received01/17/1986
Decision Date 02/19/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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