The following data is part of a premarket notification filed by New England Medical Corp. with the FDA for Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018.
| Device ID | K002042 |
| 510k Number | K002042 |
| Device Name: | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | NEW ENGLAND MEDICAL CORP. 2274 ALBANY POST RD. Walden, NY 12586 |
| Contact | Steven Fodor |
| Correspondent | Steven Fodor NEW ENGLAND MEDICAL CORP. 2274 ALBANY POST RD. Walden, NY 12586 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-05 |
| Decision Date | 2001-02-01 |