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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 -4908
Applicant Contact MARTHA C MILLER
Correspondent
CONMED CORPORATION
525 FRENCH ROAD
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
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