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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
Original Applicant
ASAP ENDOSCOPIC PRODUCTS GMBH
amstel 320-i
amsterdam,  NL 1017ap
Original Contact angelika scherp
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/26/2012
Decision Date 01/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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