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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 K130778
Device Name DISCOSCOPES, CERVICAL ENDOSCOPES
Applicant
Rz Medizintechnik GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact ANDRE WEINGREL
Correspondent
Rz Medizintechnik GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact ANDRE WEINGREL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/21/2013
Decision Date 04/14/2014
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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