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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K911165
Device Name SCREW, BONE, MAXILLOFACIAL
Applicant
Tekno-Medical
C/O Intl. Hospital Supply Co.
18321 Ventura Blvd., Suite 1010
Tarzana,  CA  91356
Applicant Contact GEORGE O SHECTER
Correspondent
Tekno-Medical
C/O Intl. Hospital Supply Co.
18321 Ventura Blvd., Suite 1010
Tarzana,  CA  91356
Correspondent Contact GEORGE O SHECTER
Regulation Number872.4880
Classification Product Code
DZL  
Date Received03/15/1991
Decision Date 08/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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