The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,housing, Ult.
| Device ID | K992813 |
| 510k Number | K992813 |
| Device Name: | 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT |
| Classification | Instrument, Biopsy |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Tamima Itani |
| Correspondent | Tamima Itani 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 | 1999-08-20 |
| Decision Date | 1999-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100987 | K992813 | 000 |