The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Vital Signs Heparin Vascular Access Flush Device.
| Device ID | K953120 |
| 510k Number | K953120 |
| Device Name: | VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Whitney Toring |
| Correspondent | Whitney Toring VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-05 |
| Decision Date | 1995-12-13 |