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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 K932060
Device Name MARTIN COLD LIGHT FOUNTAIN
Applicant
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Applicant Contact DONALD BARHAM
Correspondent
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Correspondent Contact DONALD BARHAM
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/29/1993
Decision Date 03/30/1994
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
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