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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 K140903
FOIA Releasable 510(k) K140903
Device Name NUVIS ARTHROSCOPE
Applicant
Integrated Endoscopy, Inc.
23141 Arroyo Vista, Suite 100
Rancho Santa Margarita,  CA  92688
Applicant Contact ANIL BHALANI
Correspondent
Integrated Endoscopy, Inc.
23141 Arroyo Vista, Suite 100
Rancho Santa Margarita,  CA  92688
Correspondent Contact ANIL BHALANI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/09/2014
Decision Date 07/17/2014
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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