The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Mammotome Ex Hand Held System.
| Device ID | K033700 |
| 510k Number | K033700 |
| Device Name: | MAMMOTOME EX HAND HELD SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Carol Sprinkle |
| Correspondent | Carol Sprinkle 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 | 2003-11-25 |
| Decision Date | 2004-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100956 | K033700 | 000 |
| 10841911100949 | K033700 | 000 |
| 00841911100560 | K033700 | 000 |
| 00841911100546 | K033700 | 000 |