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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 K955037
Device Name RIGID NEUROVIEW ENDOSCOPE
Applicant
Neuro Navigational Corp.
3180 Pullman St.
Costa Mesa,  CA  92626
Applicant Contact KAREN U SALINAS
Correspondent
Neuro Navigational Corp.
3180 Pullman St.
Costa Mesa,  CA  92626
Correspondent Contact KAREN U SALINAS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/03/1995
Decision Date 12/04/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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