The following data is part of a premarket notification filed by Alpha Unlimited, Inc. with the FDA for #556 Disposable Umbilical Cord Clamp (2).
| Device ID | K894646 |
| 510k Number | K894646 |
| Device Name: | #556 DISPOSABLE UMBILICAL CORD CLAMP (2) |
| Classification | Clamp, Umbilical |
| Applicant | ALPHA UNLIMITED, INC. P.O. BOX 808 701 NORTH GREENWOOD AVE. Clearwater, FL 33517 |
| Contact | Brent Magers |
| Correspondent | Brent Magers ALPHA UNLIMITED, INC. P.O. BOX 808 701 NORTH GREENWOOD AVE. Clearwater, FL 33517 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-09-05 |