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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 K940259
Device Name STERILE TROCAR AND 5.7MM SLEEVE
Applicant
PHX TECHNOLOGIES CORP.
POST OFFICE BOX 1059
LEWISVILLE,  TX  75067
Applicant Contact JAMES F CHAPEL
Correspondent
PHX TECHNOLOGIES CORP.
POST OFFICE BOX 1059
LEWISVILLE,  TX  75067
Correspondent Contact JAMES F CHAPEL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/21/1994
Decision Date 02/17/1994
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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