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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 K223406
Device Name SmartRelease Endoscopic Soft Tissue Release System
Applicant
Microaire Surgical Instruments
3590 Grand Forks Blvd.
Charlottesville,  VA  22911
Applicant Contact Glenn Gerstenfeld
Correspondent
Microaire Surgical Instruments
3590 Grand Forks Blvd.
Charlottesville,  VA  22911
Correspondent Contact Glenn Gerstenfeld
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Codes
EMF   KCT  
Date Received11/09/2022
Decision Date 02/02/2023
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
Recalls CDRH Recalls
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