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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K896669
Device Name WEBER PERMALOCK
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 Number888.3353
Classification Product Code
LZO  
Date Received11/27/1989
Decision Date 02/06/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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