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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(k) Number K933101
Device Name THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
Applicant
Osteomed Corp.
3150 Premier Dr.
#110
Irving,  TX  75063
Applicant Contact RICK BUSS
Correspondent
Osteomed Corp.
3150 Premier Dr.
#110
Irving,  TX  75063
Correspondent Contact RICK BUSS
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received06/24/1993
Decision Date 11/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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