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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K924611
Device Name IRRIGATION PUMP AND TUBING SET
Applicant
MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY,  OH  44094
Applicant Contact CRAIG R LANESE
Correspondent
MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY,  OH  44094
Correspondent Contact CRAIG R LANESE
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/11/1992
Decision Date 06/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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