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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K905240
Device Name VESSELOOPS
Applicant
Sparta Surgical Corp.
368 Fairview Ave.
P.O. Box 268
Hammonton,  NJ  08037
Applicant Contact CARLETON F KIMBER
Correspondent
Sparta Surgical Corp.
368 Fairview Ave.
P.O. Box 268
Hammonton,  NJ  08037
Correspondent Contact CARLETON F KIMBER
Regulation Number878.4800
Classification Product Code
KDC  
Date Received11/20/1990
Decision Date 02/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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