The following data is part of a premarket notification filed by Sts Biopolymers with the FDA for Echo-coat Ultrasound Needles.
| Device ID | K983647 |
| 510k Number | K983647 |
| Device Name: | ECHO-COAT ULTRASOUND NEEDLES |
| Classification | Device, Percutaneous, Biopsy |
| Applicant | STS BIOPOLYMERS 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey STS BIOPOLYMERS 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | MJG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-16 |
| Decision Date | 1999-01-20 |
| Summary: | summary |