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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator, laparoscopic, unipolar (and accessories)
510(k) Number K961695
Device Name ENDO-TECH LTD., TIPS
Applicant
RATIO DESIGN LAB
4040 NINE MCFARLAND, SUITE 800
ALPHERETTA,  GA  30201
Applicant Contact TIM B LUSBY
Correspondent
RATIO DESIGN LAB
4040 NINE MCFARLAND, SUITE 800
ALPHERETTA,  GA  30201
Correspondent Contact TIM B LUSBY
Regulation Number884.4160
Classification Product Code
HFG  
Date Received05/01/1996
Decision Date 07/01/1996
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
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