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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 K911936
Device Name OSTEOMED SBF SYSTEM (SBF)
Applicant
Osteomed Corp.
6062 San Fernando Rd.
Glendale,  CA  91202
Applicant Contact RICK A BUSS
Correspondent
Osteomed Corp.
6062 San Fernando Rd.
Glendale,  CA  91202
Correspondent Contact RICK A BUSS
Regulation Number872.4880
Classification Product Code
DZL  
Date Received05/01/1991
Decision Date 08/21/1991
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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