The following data is part of a premarket notification filed by Sterimed, Inc. with the FDA for Disposable Cournand, Seldinger & One-wall Needles.
| Device ID | K900664 |
| 510k Number | K900664 |
| Device Name: | DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES |
| Classification | Trocar |
| Applicant | STERIMED, INC. 10 RIVER CT. Cartersville, GA 30120 |
| Contact | Bruce R Grady |
| Correspondent | Bruce R Grady STERIMED, INC. 10 RIVER CT. Cartersville, GA 30120 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-07-18 |