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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 K082841
Device Name SPINAL FORAMINOSCOPE
Applicant
Blazejewski Medi-Tech GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
Blazejewski Medi-Tech GmbH
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/26/2008
Decision Date 09/09/2009
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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