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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cement Obturator
510(k) Number K900392
Device Name CENTERING PLUG
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 Number878.3300
Classification Product Code
LZN  
Date Received01/26/1990
Decision Date 03/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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