The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Women And Infant's Delivery Pack.
| Device ID | K912869 |
| 510k Number | K912869 |
| Device Name: | WOMEN AND INFANT'S DELIVERY PACK |
| Classification | Clamp, Umbilical |
| Applicant | WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Contact | Richard P Welch |
| Correspondent | Richard P Welch WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-28 |
| Decision Date | 1991-12-04 |