TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 – 233018


definition

Device Classification Name

electrocautery, gynecologic (and accessories)

510(k) Number K002042
Device Name TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 – 233018
Original Applicant
NEW ENGLAND MEDICAL CORP.
2274 albany post rd.
walden, 
NY 
12586

Original Contact steven fodor
Regulation Number 884.4120
Classification Product Code
HGI  
Date Received 07/05/2000
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