The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Mammotome Biopsy System Probe & Housing, Mammotome Hand-held System.
| Device ID | K030472 |
| 510k Number | K030472 |
| Device Name: | MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Michael J Crader |
| Correspondent | Michael J Crader ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-12 |
| Decision Date | 2003-10-09 |
| Summary: | summary |