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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K922685
Device Name TROCARS
Applicant
ENDOSCOPIC TECHNOLOGIES, INC.
2225 SKYLAND COURT
NORCROSS,  GA  30071
Applicant Contact FREDDIE P ANDRIENI
Correspondent
ENDOSCOPIC TECHNOLOGIES, INC.
2225 SKYLAND COURT
NORCROSS,  GA  30071
Correspondent Contact FREDDIE P ANDRIENI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/04/1992
Decision Date 04/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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