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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 K936011
Device Name INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM
Applicant
INVAMED, INC.
11202 FOREST RAIN
SAN ANTONIO,  TX  78233
Applicant Contact PHIL WOLF
Correspondent
INVAMED, INC.
11202 FOREST RAIN
SAN ANTONIO,  TX  78233
Correspondent Contact PHIL WOLF
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/16/1993
Decision Date 09/21/1994
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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