The following data is part of a premarket notification filed by Harwill Medical (pty) Ltd. with the FDA for Harwill Medical U-klip Umbilical Clamp.
| Device ID | K983204 |
| 510k Number | K983204 |
| Device Name: | HARWILL MEDICAL U-KLIP UMBILICAL CLAMP |
| Classification | Clamp, Umbilical |
| Applicant | HARWILL MEDICAL (PTY) LTD. P O BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith HARWILL MEDICAL (PTY) LTD. P O BOX 4341 Crofton, MD 21114 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1999-02-26 |