FDA 510(k) Application Details - K961695

Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)

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510(K) Number K961695
Device Name Coagulator, Laparoscopic, Unipolar (And Accessories)
Applicant RATIO DESIGN LAB
4040 NINE MCFARLAND, SUITE 800
ALPHERETTA, GA 30201 US
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Contact TIM B LUSBY
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Regulation Number 884.4160

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Classification Product Code HFG
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Date Received 05/01/1996
Decision Date 07/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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