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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K854951
Device Name PLUME Y SET
Applicant
Hospal Medical Corp.
25 Kimberly Rd.
P.O. Box 857
East Brunswick,  NJ  08816
Applicant Contact DOUGLAS L VLCHEK
Correspondent
Hospal Medical Corp.
25 Kimberly Rd.
P.O. Box 857
East Brunswick,  NJ  08816
Correspondent Contact DOUGLAS L VLCHEK
Regulation Number876.5540
Classification Product Code
FIE  
Date Received12/10/1985
Decision Date 01/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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