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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 K092977
Device Name EBERLE SHAVER SYSTEM ACCESSORIES
Applicant
Efs Eberle Feinwerktechnische Systeme
731-733 Shotgun Rd.
Ft. Lauderdale,  FL  33326
Applicant Contact GERALD GOIGITZER
Correspondent
Efs Eberle Feinwerktechnische Systeme
731-733 Shotgun Rd.
Ft. Lauderdale,  FL  33326
Correspondent Contact GERALD GOIGITZER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/25/2009
Decision Date 09/29/2010
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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