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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K904859
Device Name MOTOR DRIVEN EXTIRPATION INSTRUMENTS
Applicant
Aesculap, Inc.
875 Stanton Rd.
Burlingame,  CA  94010
Applicant Contact ROBIN BUSH
Correspondent
Aesculap, Inc.
875 Stanton Rd.
Burlingame,  CA  94010
Correspondent Contact ROBIN BUSH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/29/1990
Decision Date 03/15/1991
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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