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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K924138
Device Name OSTEOMED M3 SYSTEM (SBF SYSTEM)
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 Number872.4760
Classification Product Code
JEY  
Date Received08/18/1992
Decision Date 02/17/1993
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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