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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K002042
Device Name TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
Applicant
New England Medical Corp.
2274 Albany Post Rd.
Walden,  NY  12586
Applicant Contact STEVEN FODOR
Correspondent
New England Medical Corp.
2274 Albany Post Rd.
Walden,  NY  12586
Correspondent Contact STEVEN FODOR
Regulation Number884.4120
Classification Product Code
HGI  
Date Received07/05/2000
Decision Date 02/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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