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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K932700
Device Name CUTO(TM) TISSUE MORCELLATION SYSTEM
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact MARTHA C MILLER
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Keith M Smith
Regulation Number878.4820
Classification Product Code
GEY  
Date Received06/03/1993
Decision Date 10/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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