The following data is part of a premarket notification filed by Maternus, Inc. with the FDA for Koala Clamp, Koala Clamp And Cutter.
| Device ID | K011621 |
| 510k Number | K011621 |
| Device Name: | KOALA CLAMP, KOALA CLAMP AND CUTTER |
| Classification | Clamp, Umbilical |
| Applicant | MATERNUS, INC. P.O. BOX 782089 San Antonio, TX 78278 |
| Contact | Ronald B Hicks |
| Correspondent | Ronald B Hicks MATERNUS, INC. P.O. BOX 782089 San Antonio, TX 78278 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2001-08-10 |
| Summary: | summary |