The following data is part of a premarket notification filed by United Medical Systems, Inc. with the FDA for Schulman Double Umbilical Cord Clamp No. 1000.
| Device ID | K863645 |
| 510k Number | K863645 |
| Device Name: | SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000 |
| Classification | Clamp, Umbilical |
| Applicant | UNITED MEDICAL SYSTEMS, INC. 1901 E. CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Gabriel Deutsch |
| Correspondent | Gabriel Deutsch UNITED MEDICAL SYSTEMS, INC. 1901 E. CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-09-25 |