The following data is part of a premarket notification filed by I M, Inc. with the FDA for Umbilical Cord Clamp.
| Device ID | K880753 |
| 510k Number | K880753 |
| Device Name: | UMBILICAL CORD CLAMP |
| Classification | Clamp, Umbilical |
| Applicant | I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Contact | Bernard E Laderman |
| Correspondent | Bernard E Laderman I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-25 |
| Decision Date | 1988-04-27 |