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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K893121
Device Name ROBOTRAC (TM) RETRACTOR ARM
Applicant
AESCULAP INSTRUMENTS CORP.
875 STANTON RD.
BURLINGAME,  CA  94010
Applicant Contact ROBIN BUSH
Correspondent
AESCULAP INSTRUMENTS CORP.
875 STANTON RD.
BURLINGAME,  CA  94010
Correspondent Contact ROBIN BUSH
Regulation Number878.4800
Classification Product Code
GAD  
Date Received04/25/1989
Decision Date 06/01/1989
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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