The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Securline Umbilical Cord Clamp Clipper #3540.
| Device ID | K994263 |
| 510k Number | K994263 |
| Device Name: | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 |
| Classification | Clamp, Umbilical |
| Applicant | PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Contact | Kalyna Snylyk |
| Correspondent | Kalyna Snylyk PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-01-24 |
| Summary: | summary |