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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 K930756
Device Name LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE
Applicant
ENDO TECHNIC CORP.
430 10TH ST.
ATDC S-206
ATLANTA,  GA  30318
Applicant Contact TIM B LUSBY
Correspondent
ENDO TECHNIC CORP.
430 10TH ST.
ATDC S-206
ATLANTA,  GA  30318
Correspondent Contact TIM B LUSBY
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/12/1993
Decision Date 03/09/1994
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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