The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Rng Series Ultrasound Needle/cath. Gds.
| Device ID | K820269 |
| 510k Number | K820269 |
| Device Name: | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1982-03-23 |