The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Mammotome Hand Held Probe, Model Mhh8.
| Device ID | K003297 |
| 510k Number | K003297 |
| Device Name: | MAMMOTOME HAND HELD PROBE, MODEL MHH8 |
| Classification | Instrument, Biopsy |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Dennis Hahn |
| Correspondent | Dennis Hahn 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 | 2000-10-20 |
| Decision Date | 2001-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100994 | K003297 | 000 |