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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Rotary Bone Cutting
510(k) Number K971692
Device Name OSTEOPOWER SYSTEM AND ACCESSORIES
Applicant
OSTEOMED CORP.
3150 PREMIER DR.
#110
IRVING,  TX  75063
Applicant Contact CINDY WALTERS
Correspondent
OSTEOMED CORP.
3150 PREMIER DR.
#110
IRVING,  TX  75063
Correspondent Contact CINDY WALTERS
Regulation Number872.4120
Classification Product Code
KMW  
Date Received05/07/1997
Decision Date 06/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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