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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Bone
510(k) Number K000021
Device Name AESCULAP BONE WAX
Applicant
Aesculap, Inc.
13221 Maricotte Place
San Diego,  CA  92130
Applicant Contact STEVE REITZLER
Correspondent
Aesculap, Inc.
13221 Maricotte Place
San Diego,  CA  92130
Correspondent Contact STEVE REITZLER
Classification Product Code
MTJ  
Date Received01/04/2000
Decision Date 03/24/2000
Decision Substantially Equivalent (SESE)
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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