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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K003612
Device Name MICROSPEED EC MOTORSYSTEM GD650/GD653
Applicant
AESCULAP, INC.
3773 EXECUTIVE CENTER PKWY.
CENTER VALLEY,  PA  18034
Applicant Contact JOYCE THOMAS
Correspondent
AESCULAP, INC.
3773 EXECUTIVE CENTER PKWY.
CENTER VALLEY,  PA  18034
Correspondent Contact JOYCE THOMAS
Regulation Number882.4360
Classification Product Code
HBC  
Date Received11/22/2000
Decision Date 02/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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