The following data is part of a premarket notification filed by Balagan Medical, Inc. with the FDA for Kordklamp Umbilical Cord Clamp Applicator.
| Device ID | K951140 |
| 510k Number | K951140 |
| Device Name: | KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR |
| Classification | Clamp, Umbilical |
| Applicant | BALAGAN MEDICAL, INC. 15611 PRODUCT LN. B-14 Huntington Beach, CA 92649 |
| Contact | Stephen R Hessel |
| Correspondent | Stephen R Hessel BALAGAN MEDICAL, INC. 15611 PRODUCT LN. B-14 Huntington Beach, CA 92649 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-13 |
| Decision Date | 1995-05-25 |