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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 K934077
Device Name PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT
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 Received08/20/1993
Decision Date 01/25/1994
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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