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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osteotome
510(k) Number K771744
Device Name OSTEOTOMES FOR CUTTING BONH
Applicant
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
HWM  
Date Received09/15/1977
Decision Date 09/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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