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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Mill
510(k) Number K860016
Device Name AESCULAP BONE MILL
Applicant
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Applicant Contact RON ALLEN
Correspondent
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Correspondent Contact RON ALLEN
Regulation Number888.4540
Classification Product Code
LYS  
Date Received01/03/1986
Decision Date 03/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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