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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 K970712
Device Name LAPARO-TENSER
Applicant
L & T S.N.C. DI E. Lucini & C.
20037 Paderno Dugnano
Via E. Mahei 17/19
Milano,  IT
Applicant Contact FLAVIO LUCINI
Correspondent
L & T S.N.C. DI E. Lucini & C.
20037 Paderno Dugnano
Via E. Mahei 17/19
Milano,  IT
Correspondent Contact FLAVIO LUCINI
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/26/1997
Decision Date 07/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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