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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K880881
Device Name ARTUS DISPOSABLE SHEATHS/CUTTERS
Applicant
Acufex Microsurgical, Inc.
575 University Ave.
Norwood,  MA  02062
Applicant Contact RICHARD E FRANKO
Correspondent
Acufex Microsurgical, Inc.
575 University Ave.
Norwood,  MA  02062
Correspondent Contact RICHARD E FRANKO
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received03/02/1988
Decision Date 05/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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