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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K954509
Device Name PROBE KNIFE
Applicant
Phx Technologies Corp.
1032 Shady Oaks Dr., # 100
Denton,  TX  76205
Applicant Contact JAMES F CHAPEL
Correspondent
Phx Technologies Corp.
1032 Shady Oaks Dr., # 100
Denton,  TX  76205
Correspondent Contact JAMES F CHAPEL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/28/1995
Decision Date 11/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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