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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K911375
Device Name G-PIN
Applicant
Dr.M.A.Galluzzo
3427 N.Rockton Ave.
Rockford,  IL  61103
Applicant Contact M. A GALLUZZO
Correspondent
Dr.M.A.Galluzzo
3427 N.Rockton Ave.
Rockford,  IL  61103
Correspondent Contact M. A GALLUZZO
Regulation Number888.3040
Classification Product Code
HTY  
Date Received03/28/1991
Decision Date 09/23/1991
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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