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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K933067
Device Name PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact DONALD BARHAM
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact DONALD BARHAM
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/22/1993
Decision Date 01/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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