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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K901581
Device Name GSB ELBOW
Applicant
Allo Pro Corp.
Post Office Box 14159
Clearwater,  FL  34279
Applicant Contact K PIERPOINT
Correspondent
Allo Pro Corp.
Post Office Box 14159
Clearwater,  FL  34279
Correspondent Contact K PIERPOINT
Regulation Number888.3150
Classification Product Code
JDC  
Date Received04/04/1990
Decision Date 10/22/1990
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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