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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 K003740
Device Name MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
Applicant
Aesculap, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Applicant Contact DAVID W SCHLERF
Correspondent
Aesculap, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Correspondent Contact DAVID W SCHLERF
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GZT  
Date Received12/04/2000
Decision Date 04/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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