The following data is part of a premarket notification filed by Care Medical Devices, Inc. with the FDA for One-site Iv Connector.
| Device ID | K932789 |
| 510k Number | K932789 |
| Device Name: | ONE-SITE IV CONNECTOR |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CARE MEDICAL DEVICES, INC. 1440 SOUTH CARLOS AVE. Ontario, CA 91761 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard CARE MEDICAL DEVICES, INC. 1440 SOUTH CARLOS AVE. Ontario, CA 91761 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1994-07-28 |