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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 K990372
Device Name MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
Applicant
Dr. Fritz GmbH
13311 Brooks Dr., Suite E
Baldwin Park,  CA  91706
Applicant Contact JAMES CHITTY
Correspondent
Dr. Fritz GmbH
13311 Brooks Dr., Suite E
Baldwin Park,  CA  91706
Correspondent Contact JAMES CHITTY
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/08/1999
Decision Date 10/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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