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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screwdriver, Surgical
510(k) Number K896589
Device Name MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
Applicant
Optik
2131espey Court
Suite 7
Criftib,  MD  21114
Applicant Contact WILLIAM M MACFIE
Correspondent
Optik
2131espey Court
Suite 7
Criftib,  MD  21114
Correspondent Contact WILLIAM M MACFIE
Regulation Number878.4800
Classification Product Code
LRZ  
Date Received11/21/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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