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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, Resorbable, Hard Tissue
510(k) Number K901456
Device Name ORTHOSORB(R) ABSORBABLE PIN
Applicant
Johnson & Johnson International
100 Bay State Dr.
Braintree,  MA  02184
Applicant Contact MARSHA J STONE
Correspondent
Johnson & Johnson International
100 Bay State Dr.
Braintree,  MA  02184
Correspondent Contact MARSHA J STONE
Regulation Number888.3040
Classification Product Code
OVZ  
Date Received03/27/1990
Decision Date 08/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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