The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Neosoft Umbilical Vessel Catheter.
| Device ID | K883866 |
| 510k Number | K883866 |
| Device Name: | NEOSOFT UMBILICAL VESSEL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto, CA 94303 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto, CA 94303 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-11-21 |