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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 K932033
Device Name LAPAROSCOPIC SURGERY INSTRUMENTS
Applicant
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Applicant Contact MARY O'SULLIVAN
Correspondent
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN,  IL  60060
Correspondent Contact MARY O'SULLIVAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/27/1993
Decision Date 06/19/1995
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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