The following data is part of a premarket notification filed by Amedic Usa with the FDA for Transvaginal Ultrasound Biopsy Needle Guide.
| Device ID | K864219 |
| 510k Number | K864219 |
| Device Name: | TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | AMEDIC USA 3702 EAST ROESER RD, STE 27,P.O.B.62404 Phoenix, AZ 85040 -3969 |
| Contact | Jack Moore |
| Correspondent | Jack Moore AMEDIC USA 3702 EAST ROESER RD, STE 27,P.O.B.62404 Phoenix, AZ 85040 -3969 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1987-03-27 |