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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tendon, Passive
510(k) Number K930125
Device Name PHOENIX BONE SCREWS PBS-TYPE SERIES
Applicant
Phoenix Bioengineering, Inc.
Third And Mill St.s
P.O. Box 96
Bridgeport,  PA  19405
Applicant Contact HORACE J WILMER
Correspondent
Phoenix Bioengineering, Inc.
Third And Mill St.s
P.O. Box 96
Bridgeport,  PA  19405
Correspondent Contact HORACE J WILMER
Regulation Number888.3025
Classification Product Code
HXA  
Date Received01/12/1993
Decision Date 12/30/1993
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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