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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 K181819
Device Name SMARTRELEASE Endoscopic Soft Tissue Release System
Applicant
Microaire Surgical Instruments, LLC
3590 Grand Forks Blvd.
Charlottesville,  VA  22911
Applicant Contact Glenn Gerstenfeld
Correspondent
Ambriel Associates, Inc.
411 Walnut St. Unit 9236
Green Cove Springs,  FL  32043
Correspondent Contact Vikki M. O'Connor
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Codes
EMF   KCT  
Date Received07/09/2018
Decision Date 11/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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