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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 K121261
Device Name ASAP MUITISCOPE
Applicant
Asap Endoscopic Products GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
Asap Endoscopic Products GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/26/2012
Decision Date 01/08/2013
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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